Cleared Traditional

TROCAR (FALLER STYLET)

K910786 · Accurate Surgical Instruments Co. · Gastroenterology & Urology
Sep 1991
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K910786 is an FDA 510(k) clearance for the TROCAR (FALLER STYLET), a Catheter, Peritoneal, Long-term Indwelling (Class II — Special Controls, product code FJS), submitted by Accurate Surgical Instruments Co. (Toronto Canado M5v 1y9, CA). The FDA issued a Cleared decision on September 19, 1991, 206 days after receiving the submission on February 25, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K910786 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1991
Decision Date September 19, 1991
Days to Decision 206 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FJS — Catheter, Peritoneal, Long-term Indwelling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630

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