Cleared Traditional

K771412 - LIGACLIP MULTIPLE CLIP APPLIER (FDA 510(k) Clearance)

Nov 1977
Decision
119d
Days
Class 1
Risk

K771412 is an FDA 510(k) clearance for the LIGACLIP MULTIPLE CLIP APPLIER. This device is classified as a Applier, Surgical, Clip (Class I - General Controls, product code GDO).

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 878.4800.

Submission Details

510(k) Number K771412 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 GDO — Applier, Surgical, Clip
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800