United States Surgical, A Division of Tyco Healthc
Norwalk, CT, US
United States Surgical, A Division of Tyco Healthc appears in FDA device records in Norwalk, CT. FDA records list 218 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 218
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 218FDA records hold 218 510(k) clearances for United States Surgical, A Division of Tyco Healthc between 1977 and 2007. The busiest year on record is 1994, with 32. The most recent is 2007, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 6 |
| 1978 | 1 |
| 1979 | 2 |
| 1980 | 2 |
| 1981 | 3 |
| 1983 | 2 |
| 1984 | 2 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 3 |
| 1988 | 2 |
| 1989 | 7 |
| 1990 | 24 |
| 1991 | 16 |
| 1992 | 9 |
| 1993 | 11 |
| 1994 | 32 |
| 1995 | 17 |
| 1996 | 15 |
| 1997 | 13 |
| 1998 | 13 |
| 1999 | 8 |
| 2000 | 5 |
| 2001 | 6 |
| 2002 | 3 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 4 |
| 2007 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K071406 | AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER | FZP | Substantially Equivalent | |
| K071920 | AUTOSUTURE ABSORBABLE TACK AND APPLICATOR | GDW | Substantially Equivalent | |
| K061288 | AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER | FZP | Substantially Equivalent | |
| K062850 | AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS | GDW | Substantially Equivalent | |
| K062326 | AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE | GCJ | Substantially Equivalent | |
| K061095 | AUTO SUTUR ENDO GIA STAPLERS | GDW | Substantially Equivalent | |
| K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE | GAW | Substantially Equivalent | |
| K042412 | MODIFIED SPACEMAKER SYSTEM | GCJ | Substantially Equivalent | |
| K040594 | HERCULON SOFT TISSUE REATTACHMENT SYSTEM | HWC | Substantially Equivalent | |
| K032696 | AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT | GDW | Substantially Equivalent | |
| K032586 | CAPROSYN ABSORBABLE SUTURE | GAM | Substantially Equivalent | |
| K024275 | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER | GDW | Substantially Equivalent | |
| K020804 | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER | GDW | Substantially Equivalent | |
| K020134 | SPIRAL RADIUS 90-D RODDING SYSTEM | KWP | Substantially Equivalent | |
| K013671 | L-25 ABSORBABLE SURIGCAL SUTURE | GAM | Substantially Equivalent | |
| K013860 | AUTO SUTURE SURGICAL STAPLES | GDW | Substantially Equivalent | |
| K013890 | SURGICAL DYNAMICS MENISCAL STAPLE | HWC | Substantially Equivalent | |
| K012539 | VERASTEP | GCJ | Substantially Equivalent | |
| K012273 | SPIRAL RADIUS 90-D SST SYSTEM | MNH | Substantially Equivalent | |
| K003709 | SURGICAL DYNAMICS MESH CAGE SYSTEM | MQP | Substantially Equivalent | |
| K010035 | IVS TUNNELLER | FTL | Substantially Equivalent | |
| K001895 | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER | GDW | Substantially Equivalent | |
| K002008 | SURGICAL DYNAMICS SPINAL RETRACTOR | HRX | Substantially Equivalent | |
| K001450 | AUTO SUTURE MICRO SURGICLIP CLIP APPLIER | FZP | Substantially Equivalent | |
| K000037 | MONOFILAMENT BIOSYN SUTURE | GAM | Substantially Equivalent | |
| K000009 | SPIRAL RADIUS RODDING SYSTEM | KWQ | Substantially Equivalent | |
| K992784 | NEXT GENERATION RODDING SYSTEM | KWQ | Substantially Equivalent | |
| K993055 | DEXIDE BIPOLAR FORCEPS II** DEVICE | GEI | Substantially Equivalent | |
| K991859 | DEXIDE BIPOLAR FORCEPS II ** DEVICE | GEI | Substantially Equivalent | |
| K983296 | AUTO SUTURE ABBI SYSTEM | KNW | Substantially Equivalent | |
| K990952 | NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES | GAT | Substantially Equivalent | |
| K990951 | MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE | GAM | Substantially Equivalent | |
| K983400 | AUTO SUTURE SITE MARKER CLIP | GDW | Substantially Equivalent | |
| K984438 | MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE | FZP | Substantially Equivalent | |
| K984342 | ANTERIOR CERVICAL PLATING SYSTEM | KWQ | Substantially Equivalent | |
| K983904 | ROGOZINSKI SPINAL ROD SYSTEM | KWP | Substantially Equivalent | |
| K983899 | THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) | KWQ | Substantially Equivalent | |
| K983293 | AUTO SUTURE LAPAROSCOPES DEVICE | GCJ | Substantially Equivalent | |
| K982575 | MESH, SURGICAL, POLYMERIC | FTL | Substantially Equivalent | |
| K983197 | SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM) | KWP | Substantially Equivalent | |
| K981935 | POLYSORB SUTURE | GAM | Substantially Equivalent | |
| K980862 | TITANIUM SPINAL ROD SYSTEM | MNH | Substantially Equivalent | |
| K981128 | SOFSILK SUTURE | GAP | Substantially Equivalent | |
| K972911 | AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER | GAT | Substantially Equivalent | |
| K980124 | SOFSILK SUTURE | GAP | Substantially Equivalent | |
| K974734 | AURORA TITANIUM SPINAL ROD SYSTEM | MNH | Substantially Equivalent | |
| K974213 | AURORA TITANIUM SPINAL ROD SYSTEM | MNH | Substantially Equivalent for Some Indications | |
| K973496 | THE AUTO SUTURE* MIBB** SYSTEM | KNW | Substantially Equivalent | |
| K965228 | FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE | MAI | Substantially Equivalent | |
| K973281 | THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* | MAI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FEBAccessories, Cleaning, For Endoscope
- FHMApparatus, Suturing, Stomach And Intestinal
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- GDOApplier, Surgical, Clip
- HRXArthroscope
- LKFCannula, Manipulator/Injector, Uterine
- GEACannula, Surgical, General & Plastic Surgery
- JOLCatheter And Tip, Suction
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- GDJClamp, Surgical, General & Plastic Surgery
- HFWClamp, Umbilical
- DXCClamp, Vascular
- FZPClip, Implantable
- FZTCutter, Surgical
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GWGEndoscope, Neurological
- FPBFilter, Infusion Line
- GENForceps, General & Plastic Surgery
- HDAForceps, Obstetrical
- GDHGouge, Surgical, General & Plastic Surgery
- GDFGuide, Needle, Surgical
- GDGHook, Surgical, General & Plastic Surgery
- KNWInstrument, Biopsy
- LRCInstrument, Ent Manual Surgical
- GKFInstrument, Hematocrit, Automated
- HAOInstrument, Surgical, Non-Powered
- LFLInstrument, Ultrasonic Surgical
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- GCILaryngoscope, Endoscope
- FCWLight Source, Fiberoptic, Routine
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- FTLMesh, Surgical, Polymeric
- GETMotor, Surgical Instrument, Pneumatic Powered
- FMINeedle, Hypodermic, Single Lumen
- HTYPin, Fixation, Smooth
- FHOPneumoperitoneum Needle
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- GADRetractor
- HAERongeur, Manual
- KBCSaw, Nasal
- HWCScrew, Fixation, Bone
- JDRStaple, Fixation, Bone
- GDWStaple, Implantable
- GDTStaple, Removable (Skin)
- GAGStapler, Surgical
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- GALSuture, Absorbable, Natural
- GANSuture, Absorbable, Synthetic
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GAOSuture, Nonabsorbable
- GAPSuture, Nonabsorbable, Silk
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GASSuture, Nonabsorbable, Synthetic, Polyester
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DRCTrocar
- FBQTrocar, Gastro-Urology
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain