Silex Medical, LLC
Southington, CT, US
SILEX MEDICAL, LLC appears in FDA device records in Southington, CT. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005110411 | 3005110411 | SILEX MEDICAL, LLC | 24 Robert Porter Rd Ste B, SOUTHINGTON, CT 06489 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1900-2025 | Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033. | 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. | Class II | Open, Classified | |
| Z-1899-2025 | Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000. | 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. | Class II | Open, Classified | |
| Z-1898-2025 | Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050. | 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. | Class II | Open, Classified | |
| Z-1897-2025 | Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030. | 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. | Class II | Open, Classified | |
| Z-1896-2025 | Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020. | 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. | Class II | Open, Classified | |
| Z-1895-2025 | Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100. | 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. | Class II | Open, Classified | |
| Z-1894-2025 | Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030. | 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. | Class II | Open, Classified | |
| Z-1893-2025 | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain