Cleared Traditional

GRASPING FORCEPS

K933261 · Surgitek · Gastroenterology & Urology
Jan 1994
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K933261 is an FDA 510(k) clearance for the GRASPING FORCEPS, a Dislodger, Stone, Flexible (Class II — Special Controls, product code FGO), submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on January 11, 1994, 189 days after receiving the submission on July 6, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4680.

Submission Details

510(k) Number K933261 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1993
Decision Date January 11, 1994
Days to Decision 189 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FGO — Dislodger, Stone, Flexible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4680

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