Cleared Traditional

K771413 - LIGACLIP MULTIPLE LIGATING CLIPS (FDA 510(k) Clearance)

Nov 1977
Decision
119d
Days
Class 2
Risk

K771413 is an FDA 510(k) clearance for the LIGACLIP MULTIPLE LIGATING CLIPS. 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 November 28, 1977, 119 days after receiving the submission on August 1, 1977.

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

Submission Details

510(k) Number K771413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1977
Decision Date November 28, 1977
Days to Decision 119 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