Cleared Traditional

INSERTION

K920515 · Accurate Surgical Instruments Co. · Gastroenterology & Urology
May 1992
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K920515 is an FDA 510(k) clearance for the INSERTION, 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 May 4, 1992, 90 days after receiving the submission on February 4, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K920515 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1992
Decision Date May 04, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

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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