Cleared Traditional

ETHICON EXTERNAL FIXATION WIRE

K821178 · Ethicon, Inc. · General & Plastic Surgery
Jun 1983
Decision
410d
Days
Class 1
Risk

About This 510(k) Submission

K821178 is an FDA 510(k) clearance for the ETHICON EXTERNAL FIXATION WIRE, a Appliance, Facial Fracture, External (Class I — General Controls, product code FYI), submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on June 11, 1983, 410 days after receiving the submission on April 27, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3250.

Submission Details

510(k) Number K821178 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1982
Decision Date June 11, 1983
Days to Decision 410 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FYI — Appliance, Facial Fracture, External
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.3250

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