The Anspach Effort, Inc.
Palm Bch Gdns, FL, US
THE ANSPACH EFFORT, INC. appears in FDA device records in Palm Bch Gdns, FL. FDA records list 60 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 303 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 60FDA records hold 60 510(k) clearances for The Anspach Effort, Inc. between 1980 and 2022. The busiest year on record is 1982, with 9. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 8 |
| 1981 | 6 |
| 1982 | 9 |
| 1983 | 2 |
| 1984 | 1 |
| 1985 | 2 |
| 1986 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 3 |
| 1998 | 3 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 2 |
| 2007 | 2 |
| 2008 | 2 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | HBC | Substantially Equivalent | |
| K183545 | Anspach Helix Dissection Tools | HBE | Substantially Equivalent | |
| K180063 | OCM-G1 Attachment | ERL | Substantially Equivalent | |
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | HBC | Substantially Equivalent | |
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | ERL | Substantially Equivalent | |
| K113476 | ANSPACH DISSECTION TOOLS | HBE | Substantially Equivalent | |
| K082637 | CRANIAL PERFORATOR | HBF | Substantially Equivalent | |
| K080802 | EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL | HBE | Substantially Equivalent | |
| K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | HBB | Substantially Equivalent | |
| K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | HWE | Substantially Equivalent | |
| K052572 | ANSPACH KNOTLESS ANCHOR | MBI | Substantially Equivalent | |
| K050628 | ANSPACH COUPLER | HBE | Substantially Equivalent | |
| K042783 | ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM | HBE | Substantially Equivalent | |
| K040186 | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM | HBB | Substantially Equivalent | |
| K040076 | ANSPACH ADVANCED MICRO SAW ATTACHMENTS | HBE | Substantially Equivalent | |
| K030576 | ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II | FRN | Substantially Equivalent | |
| K022907 | ANSPACH POWERED KERRISON SYSTEM (PKS) | HAD | Substantially Equivalent | |
| K011444 | ANSPACH EMAX DRILL SYSTEM | HBC | Substantially Equivalent | |
| K002903 | ANSPACH ANGLED MICRONOSE ATTACHMENT | HBE | Substantially Equivalent | |
| K982991 | ANSPACH ACCESS CRANIAL PERFORATOR | HBF | Substantially Equivalent | |
| K981688 | ANSPACH SUTURE ANCHOR | MBI | Substantially Equivalent | |
| K974025 | ANSPACH SHIELDED ATTACHMENT | GFF | Substantially Equivalent | |
| K970530 | ANSPACH LUBRICATING SYSTEM II | GEY | Substantially Equivalent | |
| K965069 | ANSPACH SUTURE ANCHOR | MBI | Substantially Equivalent | |
| K965080 | ANSPACH MICROMAX SYSTEM | ERL | Substantially Equivalent | |
| K963686 | ANSPACH SUTURE ANCHOR (MODIFIED) | MBI | Substantially Equivalent | |
| K960630 | ANSPAHC SPEED REDUCER | HBB | Substantially Equivalent | |
| K955084 | ASPACH 65,000 (MODIFICATION) | HSZ | Substantially Equivalent | |
| K945525 | ANSPACH SUTURE ANCHOR | HWC | Substantially Equivalent | |
| K940535 | AUTO LUBE SYSTEM | GEY | Substantially Equivalent | |
| K921338 | ANSPACH MINI-PLATING SYSTEM | HRS | Substantially Equivalent | |
| K864314 | EFTEKHAR RECHANNELIZATION DRILL GUIDE | HSZ | Substantially Equivalent | |
| K852592 | CO2 FOR ARTHROSCOPY | HRX | Substantially Equivalent | |
| K850389 | MULTIPLE OUTLET MANIFOLD | GEY | Substantially Equivalent | |
| K841296 | TUBE TENDER | KRI | Substantially Equivalent | |
| K831756 | ANSPACH 65,000 | HSZ | Substantially Equivalent | |
| K830721 | WIRE TWISTERS | HTC | Substantially Equivalent | |
| K822065 | KAM SUCKER | KDC | Substantially Equivalent | |
| K820777 | MINI-MICRO ARTHROSCOPIC SCAPEL | HRX | Substantially Equivalent | |
| K820289 | ANTHROSCOPIC SURGICAL TABLE | FWZ | Substantially Equivalent | |
| K820776 | CANNUOATED TROCHAR | HRX | Substantially Equivalent | |
| K820291 | KNEE SUPPORT FOR X-RAY & SURGERY | FWZ | Substantially Equivalent | |
| K820290 | SELF RETAINING RETRACTOR FOR HAND SURG | GAD | Substantially Equivalent | |
| K820292 | EXTRACTOR III | Substantially Equivalent | ||
| K820293 | BONE BIOPSY SET | KNW | Substantially Equivalent | |
| K820275 | ARTHROSCOPIC HARPOON | HRX | Substantially Equivalent | |
| K811996 | GATOR DRAPES | KKX | Substantially Equivalent | |
| K811717 | GATOR DRAPES | KQM | Substantially Equivalent | |
| K811115 | SUPERFLOW CANNULA FOR ARTHROS. SURGERY | Substantially Equivalent | ||
| K811081 | MEDULLARY CANAL SCRAPERS | HTO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1045834 | 1045834 | THE ANSPACH EFFORT, INC. | 4500 RIVERSIDE DR., Palm Bch Gdns, FL 33410 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- HRXArthroscope
- MOQBattery, Replacement, Rechargeable
- HTWBit, Drill
- GFABlade, Saw, General & Plastic Surgery, Surgical
- EQJBur, Ear, Nose And Throat
- GFFBur, Surgical, General & Plastic Surgery
- HTTBurr, Orthopedic
- KQMCamera, Surgical And Accessories
- FZSCurette, Surgical, General Use
- KKXDrape, Surgical, Antimicrobial
- DZIDrill, Bone, Powered
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- DZJDriver, Wire, And Bone Drill, Manual
- HWBExtractor
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- FZXGuide, Surgical, Instrument
- FXRHolder, Camera, Surgical
- KNWInstrument, Biopsy
- MDMInstrument, Manual, Surgical, General Use
- KDCInstrument, Surgical, Disposable
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- HBCMotor, Drill, Electric
- HBBMotor, Drill, Pneumatic
- GEYMotor, Surgical Instrument, Ac-Powered
- FWZOperating Room Accessories Table Tray
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- HRSPlate, Fixation, Bone
- HTCPliers, Surgical
- FRNPump, Infusion
- HTOReamer
- GADRetractor
- HADRongeur, Powered
- HWCScrew, Fixation, Bone
- EPWSupport, Head, Surgical, Ent
- CCXSupport, Patient Position
- BWNTable And Attachments, Operating-Room
- LRPTray, Surgical
Recall records
Showing 25 of 303| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0924-2023 | Pediatric Craniotome Ref:CRANI-P-G1 | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury | Class II | Open, Classified | |
| Z-0923-2023 | 6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury | Class II | Open, Classified | |
| Z-0922-2023 | 7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury | Class II | Open, Classified | |
| Z-0921-2023 | Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury | Class II | Open, Classified | |
| Z-0920-2023 | 7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury | Class II | Open, Classified | |
| Z-0919-2023 | 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury | Class II | Open, Classified | |
| Z-0918-2023 | Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury | Class II | Open, Classified | |
| Z-0917-2023 | 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury | Class II | Open, Classified | |
| Z-0916-2023 | 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury | Class II | Open, Classified | |
| Z-0398-2018 | OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue. | This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account. | Class II | Terminated | |
| Z-2032-2017 | 20.2cm Heavy Duty Long Heavy Short Attachment | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2031-2017 | Sagittal MICRO-SAW | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2030-2017 | 5.0cm Heavy Duty Short Attachment | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2029-2017 | 5.0cm Short Attachment | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2028-2017 | SMALL ATTACHMENT, J-LATCH | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2027-2017 | SMALL ATTACHMENT, JACOBS CHUCK | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2026-2017 | Reciprocating MICRO SAW | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2025-2017 | 7.5cm QD Angle Attachment | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2024-2017 | 8cm QD Angle Attachment | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2023-2017 | 14cm QD Angle Attachment | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2022-2017 | 14cm QD Angle Attachment Product Usage: Pneumatic system | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2021-2017 | 10.5cm QD Angle Attachment Product Usage: Pneumatic system | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2020-2017 | 11cm QD Angle Attachment Product Usage: Pneumatic system | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2019-2017 | Oscillating MICRO-SAW Product Usage: Pneumatic system | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated | |
| Z-2018-2017 | 90 degree Contra Angle Attachment Product Usage: Pneumatic system | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain