Cleared Traditional

K920847 - ETHICON LIGACLIP ENDO LD APPLIER/DIVIDER (FDA 510(k) Clearance)

May 1992
Decision
94d
Days
Class 2
Risk

K920847 is an FDA 510(k) clearance for the ETHICON LIGACLIP ENDO LD APPLIER/DIVIDER. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).

Submitted by Ethicon, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 29, 1992, 94 days after receiving the submission on February 25, 1992.

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

Submission Details

510(k) Number K920847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1992
Decision Date May 29, 1992
Days to Decision 94 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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