Cleared Traditional

GAUZE CHERRY SPONGE

K872809 · American Silk Sutures, Inc. · General & Plastic Surgery
Aug 1987
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K872809 is an FDA 510(k) clearance for the GAUZE CHERRY SPONGE, a Gauze/sponge, Internal, X-ray Detectable (Class I — General Controls, product code GDY), submitted by American Silk Sutures, Inc. (Lynn, US). The FDA issued a Cleared decision on August 4, 1987, 21 days after receiving the submission on July 14, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4450.

Submission Details

510(k) Number K872809 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1987
Decision Date August 04, 1987
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GDY — Gauze/sponge, Internal, X-ray Detectable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4450

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