Data / Medical devices / United States / Key Surgical, LLC
Key Surgical, LLC: FDA-registered device maker in Eden Prairie, MN, United States, 11 510(k) clearances
Key Surgical, LLC is registered with the FDA (registration 2183785) in Eden Prairie, MN, United States. It lists 27 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 15, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2183785
- Address
- 8101 Wallace Road, Eden Prairie, MN, United States, 55344
- Owner or operator
- STERIS Corporation (10023158)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 7, 2007
- Registered through
- 2027
- Brand names listed
- Acetabular Brush, BOWLS BASINS and PITCHERS MEDICINE CUP, Bone Reamer Brush, Cautery Tip Cleaner, Corner Protector (KS-SD,RR), Dressing Jar, Drill Bits, Electro Lube (EL101) (KS-SD) and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 15, 2025 | K242773 | Electro Lube NXT | GEI | Substantially Equivalent | Steris | accessdata.fda.gov |
| May 31, 2024 | K241055 | Electro Lube NXT | GEI | Substantially Equivalent | Steris | accessdata.fda.gov |
| June 29, 2017 | K171533 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | FRG | Substantially Equivalent | Ahlstrom Nonwovens, LLC | accessdata.fda.gov |
| July 27, 2016 | K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | FRG | Substantially Equivalent | Ahlstrom Nonwovens, LLC | accessdata.fda.gov |
| May 22, 2015 | K151222 | Cautery Tip Cleaner | GEI | Substantially Equivalent | Key Surgical, Inc. | accessdata.fda.gov |
| May 13, 2011 | K102845 | MAHE FIXATION PLATE AND SCREW SYSTEM | HRS | Substantially Equivalent | Mahe Medical GmbH | accessdata.fda.gov |
| March 10, 2004 | K033880 | ELECTRO-LUBE | GEI | Substantially Equivalent | Mectra Labs, Inc. | accessdata.fda.gov |
| March 3, 2000 | K993604 | ENDOSCOPIC ANTI FOG DEVICE | OCT | Substantially Equivalent | Mectra Labs, Inc. | accessdata.fda.gov |
| August 11, 1993 | K932449 | DR. FOG | OCT | Substantially Equivalent | O.R. Concepts, Inc. | accessdata.fda.gov |
| February 27, 1990 | K896676 | KEY VASCULAR LOOPS | KDC | Substantially Equivalent | Key Surgical, Inc. | accessdata.fda.gov |
| August 7, 1989 | K890759 | STRIP, STERILIZATION INDICATOR; STEAM | JOJ | Substantially Equivalent | Spsmedical Supply Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Utensil, Homemaking
- All makers of Tray, Surgical
- All makers of Wrap, Sterilization
- All makers of Bit, Drill
- All makers of Anti Fog Solution And Accessories, Endoscopy
- All makers of Instrument, Manual, Surgical, General Use
Updated April 15, 2025. 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.