Cleared Traditional

K834267 - LIGACLIP METALLIC LIGATING CLIP (FDA 510(k) Clearance)

Mar 1984
Decision
95d
Days
Class 2
Risk

K834267 is an FDA 510(k) clearance for the LIGACLIP METALLIC LIGATING CLIP. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).

Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1984, 95 days after receiving the submission on December 8, 1983.

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

Submission Details

510(k) Number K834267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1983
Decision Date March 12, 1984
Days to Decision 95 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