Cleared Traditional

LAP SPONGES, MODIFIED

K913303 · Carwild Corp. · General & Plastic Surgery
Aug 1992
Decision
378d
Days
Class 1
Risk

About This 510(k) Submission

K913303 is an FDA 510(k) clearance for the LAP SPONGES, MODIFIED, a Gauze/sponge, Internal, X-ray Detectable (Class I — General Controls, product code GDY), submitted by Carwild Corp. (Old Mystic, US). The FDA issued a Cleared decision on August 6, 1992, 378 days after receiving the submission on July 25, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4450.

Submission Details

510(k) Number K913303 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1991
Decision Date August 06, 1992
Days to Decision 378 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

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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