Cleared Traditional

LOOSE BODY GRASPERS

K870881 · Bowen & Company, Inc. · General & Plastic Surgery
Mar 1987
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K870881 is an FDA 510(k) clearance for the LOOSE BODY GRASPERS, a Forceps (Class I — General Controls, product code HTD), submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on March 23, 1987, 18 days after receiving the submission on March 5, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K870881 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1987
Decision Date March 23, 1987
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HTD — Forceps
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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