Data / Medical devices / United States / Silex Medical, LLC
Silex Medical, LLC: FDA-registered device maker in Southington, CT, United States, 3 510(k) clearances
Silex Medical, LLC is registered with the FDA (registration 3005110411) in Southington, CT, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 26, 1995. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005110411
- Address
- 24 Robert Porter Rd Ste B, Southington, CT, United States, 06489
- Owner or operator
- SILEX MEDICAL, LLC (9071595)
- Roles
- Manufacturer
- First device listed
- August 3, 2006
- Registered through
- 2026
- Brand names listed
- Gray Line, SSI, Signature Line
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 26, 1995 | K946263 | BRIMFIELD PRECISION GRASPER/DISSECTOR | GCJ | Substantially Equivalent | Springfield Surgical Instruments | accessdata.fda.gov |
| October 15, 1993 | K933387 | BRIMFIELD PRECISION GRASPER/DISSECTOR | GCJ | Substantially Equivalent | Springfield Surgical Instruments | accessdata.fda.gov |
| January 6, 1992 | K914910 | DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE) | GEI | Substantially Equivalent | Davol, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 9, 2024 | 96755 | Class II | Ongoing | Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5860020. | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated June 2, 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.