Cleared Traditional

K853015 - SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420
(FDA 510(k) Clearance)

K853015 · The Huxley Instrument Corp. · General & Plastic Surgery
Jul 1985
Decision
12d
Days
Class 1
Risk

K853015 is an FDA 510(k) clearance for the SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420, a Forceps, General & Plastic Surgery (Class I — General Controls, product code GEN), submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on July 29, 1985, 12 days after receiving the submission on July 17, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K853015 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1985
Decision Date July 29, 1985
Days to Decision 12 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GEN — Forceps, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800