Cleared Traditional

K830503 - LIGACLIP TITANIUM LIGATING CLIP (FDA 510(k) Clearance)

Mar 1983
Decision
20d
Days
Class 2
Risk

K830503 is an FDA 510(k) clearance for the LIGACLIP TITANIUM LIGATING CLIP. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on March 8, 1983, 20 days after receiving the submission on February 16, 1983.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K830503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1983
Decision Date March 08, 1983
Days to Decision 20 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code FZP — Clip, Implantable
Device Class Class II - Special Controls
CFR Regulation 21 CFR 878.4300