Summit Medical, LLC
Franklin, MA, US
SUMMIT MEDICAL LLC appears in FDA device records in Franklin, MA. FDA records list 27 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 19 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Summit Medical, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Shippert Medical Technologies Corp.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 27 510(k) clearances for Summit Medical, LLC between 1995 and 2018. The busiest year on record is 1996, with 5. The most recent is 2018, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 3 |
| 1996 | 5 |
| 1997 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2005 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2014 | 4 |
| 2015 | 3 |
| 2017 | 2 |
| 2018 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K180528 | InstruSafe(R) Sterilization Container | KCT | Substantially Equivalent | |
| K173110 | GRAFTSITE | BSP | Substantially Equivalent | |
| K170388 | ANCHORMAN Tibial Ligament Fixation Device | MBI | Substantially Equivalent | |
| K162046 | MINNE TIES MMF Suture System | DYX | Substantially Equivalent | |
| K151166 | Instru-Safe Instrument Protection System | KCT | Substantially Equivalent | |
| K150540 | Instru-Safe Instrument Protection System | KCT | Substantially Equivalent | |
| K142768 | Instru-Safe Instrument Protection System | KCT | Substantially Equivalent | |
| K142630 | Instru-Safe Instrument Protection System | KCT | Substantially Equivalent | |
| K141513 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | KCT | Substantially Equivalent | |
| K140289 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | KCT | Substantially Equivalent | |
| K133015 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | KCT | Substantially Equivalent | |
| K102117 | TISSU TRANS FILTRON SYRINGE FILL | MUU | Substantially Equivalent | |
| K092482 | TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 | MUU | Substantially Equivalent | |
| K092022 | TISSU TRANS HARVEST TUBING | KYZ | Substantially Equivalent | |
| K050797 | TISSU-TRANS | KYZ | Substantially Equivalent | |
| K024097 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 | CAC | Substantially Equivalent | |
| K022477 | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET | CAK | Substantially Equivalent | |
| K022489 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 | CAC | Substantially Equivalent | |
| K964855 | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD | HOZ | Substantially Equivalent | |
| K964334 | EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) | GCJ | Substantially Equivalent | |
| K963704 | MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE | LYG | Substantially Equivalent | |
| K962133 | EXPANDACELL INJECTO-PAK | EMX | Substantially Equivalent | |
| K960621 | EXPANDACELL INSTRUMENT WIPE | GEC | Substantially Equivalent | |
| K960228 | EXPANDACELL INJECTO-PAK NASAL PACK | EMX | Substantially Equivalent | |
| K955593 | EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY | EMX | Substantially Equivalent | |
| K954845 | EXPANDACELL INJECTO-PAK NASAL PACK | EMX | Substantially Equivalent | |
| K950024 | EXPANDACELL NASAL PACK WITH AIRWAY | EMX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008719017 | 3008719017 | SUMMIT MEDICAL LLC | 815 Vikings Pkwy Ste 100, Saint Paul, MN 55121 US | 2026 | and 30 more, listed in full below |
| 9617155 | 1000345108 | SUMMIT MEDICAL LTD. | INDUSTRIAL PARK, GLOUCESTERSHIRE GL54 2HQ GB | 2026 | |
| 1222637 | 1000120904 | SUMMIT MEDICAL, INC. | 20 ADDISON AVE., FRANKLIN, MA 02038 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- CACApparatus, Autotransfusion
- KCJApplicator, Ent
- EMXBalloon, Epistaxis
- KMFBandage, Liquid
- KDQBottle, Collection, Vacuum
- GECBrush, Scrub, Operating-Room
- LFBButton, Nasal Septal
- HMXCannula, Ophthalmic
- GEACannula, Surgical, General & Plastic Surgery
- JOLCatheter And Tip, Suction
- GDJClamp, Surgical, General & Plastic Surgery
- HTFCurette
- MJVDevice, Inflation, Middle Ear
- KIHDispenser, Cement
- KCNEar Wick
- JDYEvacuator, Vapor, Cement Monomer
- JYHExcavator, Ear
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HFBForceps, Biopsy, Gynecological
- KAEForceps, Ent
- GENForceps, General & Plastic Surgery
- HWNInstrument, Compression
- KDCInstrument, Surgical, Disposable
- JYPKnife, Myringotomy
- HNNKnife, Ophthalmic
- GCJLaparoscope, General & Plastic Surgery
- FQHLavage, Jet
- QKLLipoaspirate Washing System For Aesthetic Body Contouring
- DYXLock, Wire, And Ligature, Intraoral
- LYGMassager, Therapeutic, Manual
- CAKMicrofilter, Blood Transfusion
- JDZMixer, Cement, For Clinical Use
- CAFNebulizer (Direct Patient Interface)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- LXHOrthopedic Manual Surgical Instrument
- JYTPick, Microsurgical Ear
- LZUPlug, Punctum
- EMEPunch, Biopsy, Surgical
- HNJPunch, Corneo-Scleral
- HHMSound, Uterine
- HNDSpatula, Ophthalmic
- HDFSpeculum, Vaginal, Metal
- LYASplint, Intranasal Septal
- EPPSplint, Nasal
- HOZSponge, Ophthalmic
- FOXStand, Infusion
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- EJISyringe, Cartridge
- KYZSyringe, Irrigating (Non Dental)
- MUUSystem, Suction, Lipoplasty
- HRHTrephine, Manual, Ophthalmic
- BYYTube, Aspirating, Flexible, Connecting
- JZFTube, Ear Suction
- ETDTube, Tympanostomy
- FPKTubing, Fluid Delivery
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1171-2023 | Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. | Sterile product pouches were not sealed. | Class II | Open, Classified | |
| Z-1336-2019 | Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO. | The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch. | Class II | Completed | |
| Z-1335-2019 | Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO. | The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch. | Class II | Completed | |
| Z-1334-2019 | Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO. | Class II | Completed | ||
| Z-1333-2019 | Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO. | Class II | Completed | ||
| Z-1332-2019 | Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO. | The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch. | Class II | Completed | |
| Z-1331-2019 | Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO. | The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch. | Class II | Completed | |
| Z-1330-2019 | Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO. | The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch. | Class II | Completed | |
| Z-0170-2018 | Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction. | Potential breach of sterility of the packaging. | Class II | Terminated | |
| Z-3066-2017 | Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction. | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Terminated | |
| Z-3065-2017 | Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction. | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Terminated | |
| Z-3064-2017 | Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer and liposuction. | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Terminated | |
| Z-3063-2017 | Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer and liposuction. | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Terminated | |
| Z-3062-2017 | Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction. | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Terminated | |
| Z-3061-2017 | Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and liposuction. | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Terminated | |
| Z-3060-2017 | Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction. | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Class II | Terminated | |
| Z-0435-2016 | AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity. | Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog # RH-7413-10, Lot # 160889 & 161354 because the product does not have the split in the packing. | Class II | Terminated | |
| Z-1731-2014 | Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane. | One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient. | Class II | Terminated | |
| Z-1319-2013 | Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane. | Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the wrong blade. The box contains Myringotomy Spear Blade (Juvenile). | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Summit Medical, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain