Identifiers
- 510(k) Number
- K073613 FDA 510(k)
- FDA Product Code
- NUJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Reprocessed Scissor Tips are electrosurgical cutting and coagulation accessories designed for laparoscopic and endoscopic procedures. These single-use devices are intended for use with compatible handpieces and generators to facilitate tissue dissection and cauterization during surgical interventions.
These reprocessed tips are supplied sterile and are classified as Class II devices under FDA regulation 878.4400. They are intended for reuse after reprocessing and are compatible with various electrosurgical systems. The device holds an FDA 510(k) clearance (K073613) under the Traditional pathway, with a decision date of February 12, 2008, and is substantively equivalent to comparable electrosurgical scissor inserts.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: REPROCESSED SCISSOR TIPS (K073613) — FDA 510 (k) | Innolitics, Reprocessed Scissor Tips - Sterilmed | FDA Reference, PDF Ml~d~c.,..& RmneesDECEMBER20, - Food and Drug Administration, Reprocessed Scissor Tips 510 (k) FDA Premarket Notification K073613 ..., Medical Reprocessing | Sustainability | J&J MedTech
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073613 | Class II | Active |
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Manufacturer
- Manufacturer
- Sterilmed, Inc.
Sources (1)
- FDA 510(k) K073613 24 fields · synced Sep 19, 2026