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Data / Medical devices / United States / Summit Medical LLC

Summit Medical LLC: FDA-registered device maker in Saint Paul, MN, United States, 20 510(k) clearances

Summit Medical LLC is registered with the FDA (registration 3008719017) in Saint Paul, MN, United States. It lists 40 device types. The FDA files 20 510(k) clearances under its listings, the newest dated November 30, 2021. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Summit Medical LLC
FDA registration number
3008719017
Address
815 Vikings Pkwy Ste 100, Saint Paul, MN, United States, 55121
Owner or operator
Summit Medical, LLC (10033920)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
October 19, 2010
Registered through
2026
Brand names listed
AbsorbENT Ear, AbsorbENT Nasal, Apdyne Phenol Applicator Kit, Aspiration Tubing, Bi-Valve Nasal Splint, Breeze Nasal Splint, CORONET® DMEK EndoGlide™, CORONET® Donor Corneal Trephine Punch and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Specification developeraccessdata.fda.gov
Applicator, EntKCJ1Manufactureraccessdata.fda.gov
Balloon, EpistaxisEMX1Manufactureraccessdata.fda.gov
Bandage, LiquidKMF1Manufacturer for exportaccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Button, Nasal SeptalLFBUManufactureraccessdata.fda.gov
Cannula, OphthalmicHMX1Contract manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Complaint file establishmentaccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Manufacturer, Specification developeraccessdata.fda.gov
Device, Inflation, Middle EarMJVUContract manufacturer, Manufactureraccessdata.fda.gov
Ear WickKCN1Contract manufacturer, Manufactureraccessdata.fda.gov
Excavator, EarJYH1Complaint file establishmentaccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Complaint file establishmentaccessdata.fda.gov
Forceps, EntKAE1Complaint file establishmentaccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Complaint file establishmentaccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Contract manufacturer, Manufactureraccessdata.fda.gov
Knife, MyringotomyJYP1Manufactureraccessdata.fda.gov
Knife, OphthalmicHNN1Contract manufactureraccessdata.fda.gov
Lipoaspirate Washing System For Aesthetic Body ContouringQKL2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Contract manufacturer, Manufactureraccessdata.fda.gov
Pick, Microsurgical EarJYT1Manufactureraccessdata.fda.gov
Plug, PunctumLZUUComplaint file establishment, Manufactureraccessdata.fda.gov
Punch, Biopsy, SurgicalEME1Complaint file establishmentaccessdata.fda.gov
Punch, Corneo-ScleralHNJ1Complaint file establishmentaccessdata.fda.gov
Sound, UterineHHM1Complaint file establishmentaccessdata.fda.gov
Spatula, OphthalmicHND1Complaint file establishmentaccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Complaint file establishmentaccessdata.fda.gov
Splint, Intranasal SeptalLYA1Contract manufacturer, Manufactureraccessdata.fda.gov
Splint, NasalEPP1Contract manufacturer, Manufacturer, Manufacturer for exportaccessdata.fda.gov
Sponge, OphthalmicHOZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Stand, InfusionFOX1Manufactureraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Manufactureraccessdata.fda.gov
Syringe, CartridgeEJI2Complaint file establishmentaccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Manufactureraccessdata.fda.gov
System, Suction, LipoplastyMUU2Manufactureraccessdata.fda.gov
Trephine, Manual, OphthalmicHRH1Complaint file establishmentaccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Repackager or relabeleraccessdata.fda.gov
Tube, Ear SuctionJZF1Manufactureraccessdata.fda.gov
Tube, TympanostomyETD2Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 30, 2021K210836InstruSafe Instrument Protection SystemKCTSubstantially EquivalentSummitt Medical, LLCaccessdata.fda.gov
November 16, 2018K180528InstruSafe(R) Sterilization ContainerKCTSubstantially EquivalentSummit Medical, Inc.accessdata.fda.gov
August 18, 2015K151166Instru-Safe Instrument Protection SystemKCTSubstantially EquivalentSummit Medical, Inc.accessdata.fda.gov
June 22, 2015K150540Instru-Safe Instrument Protection SystemKCTSubstantially EquivalentSummit Medical, Inc.accessdata.fda.gov
May 29, 2015K142768Instru-Safe Instrument Protection SystemKCTSubstantially EquivalentSummit Medical, Inc.accessdata.fda.gov
December 23, 2014K142630Instru-Safe Instrument Protection SystemKCTSubstantially EquivalentSummit Medical, Inc.accessdata.fda.gov
December 15, 2014K141513INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMKCTSubstantially EquivalentSummit Medical, Inc.accessdata.fda.gov
June 27, 2014K140289INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMKCTSubstantially EquivalentSummit Medical, Inc.accessdata.fda.gov
March 13, 2014K133015INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMKCTSubstantially EquivalentSummit Medical, Inc.accessdata.fda.gov
December 4, 2009K092482TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500MUUSubstantially EquivalentShippert Medical Technologies Corp.accessdata.fda.gov
September 1, 2009K092284LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200MUUSubstantially EquivalentMedical Device Resource Corp.accessdata.fda.gov
March 14, 2008K073401EARPOPPER, MODEL EP-2000, EP-2100, EP-3000MJVSubstantially EquivalentMicromedics, Inc.accessdata.fda.gov
September 1, 2005K051157INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSKCTSubstantially EquivalentMicromedics, Inc.accessdata.fda.gov
May 9, 2003K030300OPAQUE HERRICK LACRIMAL PLUGLZUSubstantially EquivalentLacrimedics, Inc.accessdata.fda.gov
August 26, 1999K991670SILVERSTEIN MICROWICKETDSubstantially EquivalentMicromedics, Inc.accessdata.fda.gov
November 24, 1998K982667MICROMEDICS NASAL SEPTAL BUTTONLFBSubstantially EquivalentMicromedics, Inc.accessdata.fda.gov
October 7, 1991K911785RHINO-GUARDCAFSubstantially EquivalentMicromedics, Inc.accessdata.fda.gov
March 3, 1986K854359LM2000A SURGICAL SUCTION MONITORKDQSubstantially EquivalentEngineering, Inc.accessdata.fda.gov
October 14, 1983K832680MICRO-EDGE DISPOSABLE BLADESKDCSubstantially EquivalentMicromedics, Inc.accessdata.fda.gov
March 7, 1983K830228OTOLOGICAL VENTILATION TUBES-VARIOUSETDSubstantially EquivalentMicromedics, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
January 13, 202391527Class IITerminatedSummit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.Sterile product pouches were not sealed.accessdata.fda.gov
February 2, 201881837Class IICompletedTissu-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.accessdata.fda.gov
October 20, 201778392Class IITerminatedTissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.Potential breach of sterility of the packaging.accessdata.fda.gov
June 1, 201777518Class IITerminatedTissu-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.accessdata.fda.gov
September 3, 201572276Class IITerminatedAbsorbENT, 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 oSummit 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.accessdata.fda.gov
May 12, 201468267Class IITerminatedArmstrong 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.accessdata.fda.gov
March 27, 201365034Class IITerminatedSummit 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).accessdata.fda.gov

Compare with other makers

Updated February 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.