Key Surgical, LLC
Eden Prairie, MN, US
Key Surgical, LLC appears in FDA device records in Eden Prairie, MN. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Key Surgical, LLC between 1989 and 2015. The busiest year on record is 1989, with 2. The most recent is 2015, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 1 |
| 2015 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K150532 | Universal Light Handle Cover, Light Handle Cover | FTA | Substantially Equivalent | |
| K151222 | Cautery Tip Cleaner | GEI | Substantially Equivalent | |
| K910328 | KEY COMFORT GRIPS | FSM | Substantially Equivalent | |
| K896676 | KEY VASCULAR LOOPS | KDC | Substantially Equivalent | |
| K896472 | KEY VASCULAR BOOTIES | MAW | Substantially Equivalent | |
| K895591 | SILICONE INSTRUMENT SHODS | GDJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2183785 | 2183785 | Key Surgical, LLC | 8101 Wallace Road, Eden Prairie, MN 55344 US | 2026 | and 17 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- OCTAnti Fog Solution And Accessories, Endoscopy
- FNYBasin, Emesis
- HTWBit, Drill
- HXDClamp
- GDJClamp, Surgical, General & Plastic Surgery
- KYWContainer, Liquid Medication, Graduated
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- MNKEndoscopic Bite Block
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- JOJIndicator, Physical/Chemical Sterilization Process
- MDMInstrument, Manual, Surgical, General Use
- KDCInstrument, Surgical, Disposable
- LYVLabel Or Tag, Sterile
- FTALight, Surgical, Accessories
- FZZMarker, Skin
- MAWMarker, Suture Identification
- GABNeedle, Suturing, Disposable
- LXHOrthopedic Manual Surgical Instrument
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- HTOReamer
- HWCScrew, Fixation, Bone
- CCXSupport, Patient Position
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
- FNPUrinal
- IKWUtensil, Homemaking
- FRGWrap, Sterilization
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