Cleared Traditional

TITANIUM CONNECTOR (2 PART)

K910787 · Accurate Surgical Instruments Co. · Gastroenterology & Urology
Aug 1991
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K910787 is an FDA 510(k) clearance for the TITANIUM CONNECTOR (2 PART), a Catheter, Peritoneal Dialysis, Single Use (Class II — Special Controls, product code FKO), submitted by Accurate Surgical Instruments Co. (Toronto Canado M5v 1y9, CA). The FDA issued a Cleared decision on August 15, 1991, 171 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 K910787 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1991
Decision Date August 15, 1991
Days to Decision 171 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FKO — Catheter, Peritoneal Dialysis, Single Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630

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