Lapro-Clip Auto Suture Reusable Long Clip Applier
FDA 510(k)Class II (US FDA 510(k))
by Covidien llc
Identifiers
- 510(k) Number
- K143598 FDA 510(k)
- FDA Product Code
- FZP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lapro-Clip Auto Suture Reusable Long Clip Applier is a reusable surgical instrument designed to apply absorbable ligating clips. It falls under the classification of a clip, implantable, and is intended for use in general and plastic surgery procedures to secure tissues or vessels during minimally invasive surgeries.
The device consists of a reusable applier with a 33cm length and 10mm shaft diameter, paired with single-use cartridges containing clips made from polyglycolic acid and polyglyconate. It is intended for reusable use in sterile surgical settings and has received FDA 510(k) clearance under the classification code FZP, with a decision of Substantially Equivalent (SESE) in 2015. The device adheres to regulation 878.4300 and is categorized under the medical specialty of General and Plastic Surgery.
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: Lapro-Clip Auto Suture Reusable Long Clip Applier (K143598) — FDA 510 ..., Lapro-Clip™ ligation system - Medtronic, PDF Lapro-Clip Auto Suture Reusable Long Clip Applier 510 (k) K143598 - FDA ..., Lapro-Clip Auto Suture Reusable Long Clip Applier (K143598) — FDA 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143598 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien llc
- FDA Applicant
- Covidien, LLC
Sources (1)
- FDA 510(k) K143598 24 fields · synced Sep 19, 2026