Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008719017

FEI Number

3008719017

Entity Name

SUMMIT MEDICAL LLC

City/State/Country

Saint Paul, MN, US

Establishment Address

815 Vikings Pkwy Ste 100, Saint Paul, MN 55121, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Summit Medical, LLC (Owner Number: 10033920)

Owner / Operator Contact Address

815 Vikings Parkway, Suite 100, Saint Paul, MN 55121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K854359

PMA Number

N/A

All Registered Proprietary Names

InstruSafe Instrument Protection System RhinoGuard Tip Covers Leur Lock Cannula Fat Grafting Cannula Toomey Cannula Harvest Cannulas Injection Cannula Disposable Cannula Frazier Suction Handles Sims Uterine Sound MicroEdge Blades Septal Button Silverstein Microwick Cusco Specula Insulated with Smoke Tube Oral Rotating Biopsy Punch Shikani Stent Nasal Splint EarPopper MicroPick Ear Pick Tips CORONET® DMEK EndoGlide Dental Syringe LS Connect InstruSafe Instrument Protection System AbsorbENT Ear Cervical Biopsy Punch TT-HOLDER Tall OR Floor Stand Infiltration Tubing Aspiration Tubing InstruSafe Instrument Protection System SYRINGE, IRRIGATING (NON DENTAL) System, suction, lipoplasty InstruSafe Instrument Protection System Dissolvable VisiPlug Lacrimal Plug Tissu-Trans FILTRON Foreign Body Removal Ventilation Tubes Shippert AestheticsTM Tissu-Trans® FILTRON® EpiStax Epistaxis Balloon Catheter Tissu-Trans FILTRON PVA Ophthalmic Implosion Resistant Canister

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-06-24
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2014-06-30
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2010-10-19
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-12-31
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-09-29
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2023-09-29
JYP	Knife, Myringotomy	Ear, Nose, Throat	Class 1	874.4420	2010-10-19
LFB	Button, Nasal Septal	Unknown	Class U	N/A	2010-10-19
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2010-10-19
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2023-09-29
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	2024-02-08
EPP	Splint, Nasal	Ear, Nose, Throat	Class 1	874.5800	2010-10-19
MJV	Device, Inflation, Middle Ear	Unknown	Class U	N/A	2010-10-19
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2012-05-18
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-09-23
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2023-09-29
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2022-02-22
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2015-05-28
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2010-10-19
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2021-09-23
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-02-22
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2024-12-27
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2025-03-28
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2019-12-31
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2015-07-16
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	Class 2	878.5040	2019-12-26
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2019-12-26
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2016-03-17
LZU	Plug, Punctum	Unknown	Class U	N/A	2022-07-20
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	General, Plastic Surgery	Class 2	878.5040	2024-12-11
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2012-05-18
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2010-10-19
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	General, Plastic Surgery	Class 2	878.5040	2025-04-18
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2012-02-09
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	Class 2	878.5040	2019-12-31
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2021-07-14
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2019-12-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Summit Medical, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

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3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL
9611502	CARL TEUFEL GMBH & CO. KG	LIPTINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008719017. Last updated year: 2026. Please use registration number 3008719017 when referencing this establishment in official correspondence.