FDA Registration
Active
🇺🇸 United States
SUMMIT MEDICAL LLC
Reg #: 3008719017
·
FEI: 3008719017
·
Expires 2026
Products
40
Proprietary Names
53
Establishment Types
6
Classifications
40
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Registration Details
- Registration Name
- SUMMIT MEDICAL LLC
- Registration Number
- 3008719017
- FEI Number
- 3008719017
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 815 Vikings Pkwy Ste 100
- City
- Saint Paul
- State
- MN
- ZIP
- 55121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140289
Owner / Operator
- Firm Name
- Summit Medical, LLC
- Operator Number
- 10033920
- Address
- 815 Vikings Parkway, Suite 100
- City
- Saint Paul
- State
- MN
- Postal Code
- 55121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2024-06-24 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2014-06-30 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2010-10-19 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2019-12-31 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2023-09-29 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2023-09-29 |
| Knife, Myringotomy | JYP | Class 1 | Ear, Nose, Throat | No | 2010-10-19 |
| Button, Nasal Septal | LFB | Class U | Unknown | No | 2010-10-19 |
| Tube, Tympanostomy | ETD | Class 2 | Ear, Nose, Throat | No | 2010-10-19 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2023-09-29 |
| Punch, Biopsy, Surgical | EME | Class 1 | Dental | No | 2024-02-08 |
| Splint, Nasal | EPP | Class 1 | Ear, Nose, Throat | No | 2010-10-19 |
| Device, Inflation, Middle Ear | MJV | Class U | Unknown | No | 2010-10-19 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2012-05-18 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2024-09-23 |
| Syringe, Cartridge | EJI | Class 2 | Dental | No | 2023-09-29 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2022-02-22 |
| Ear Wick | KCN | Class 1 | Ear, Nose, Throat | No | 2010-10-19 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2021-09-23 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2022-02-22 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2024-12-27 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2025-03-28 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2019-12-31 |
| System, Suction, Lipoplasty | MUU | Class 2 | General, Plastic Surgery | No | 2019-12-26 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2019-12-26 |
| Plug, Punctum | LZU | Class U | Unknown | No | 2022-07-20 |
| Lipoaspirate Washing System For Aesthetic Body Contouring | QKL | Class 2 | General, Plastic Surgery | No | 2024-12-11 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2012-05-18 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2012-02-09 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2021-07-14 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2013-09-21 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2023-09-29 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2010-10-19 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2010-10-19 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2010-10-19 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2023-09-29 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2024-09-23 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2023-09-29 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2024-06-24 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 2024-09-23 |
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
AbsorbENT Ear
Cervical Biopsy Punch
TT-HOLDER
Tall OR Floor Stand
Infiltration Tubing
Aspiration Tubing
SYRINGE, IRRIGATING (NON DENTAL)
System, suction, lipoplasty
Dissolvable VisiPlug Lacrimal Plug
Tissu-Trans FILTRON
Foreign Body Removal
Ventilation Tubes
Shippert AestheticsTM Tissu-Trans® FILTRON®
EpiStax Epistaxis Balloon Catheter
PVA Ophthalmic
Implosion Resistant Canister
PhenolPro Safety Applicator, GVPro Gentian Violet Applicator
Apdyne Phenol Applicator Kit
Crocodile Micro Forceps
AbsorbENT Nasal
Bi-Valve Nasal Splint
Breeze Nasal Splint
Irrigation and Infiltration Tubing
InstruSafe Sterilization Container System
MicroEdge Myringotomy Blades
Formby Cerumen Hook & Probe
Coronet DALK Recipient Trephine
Rampley Sponge Holder
The Denver Splint Kits
CORONET® Donor Corneal Trephine Vacuum Punch
CORONET® Donor Corneal Trephine Punch
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only