Cleared Traditional

4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS

K933109 · Boston Pacific Medical, Inc. · Gastroenterology & Urology
Mar 1994
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K933109 is an FDA 510(k) clearance for the 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS, a Catheter, Urological (Class II — Special Controls, product code KOD), submitted by Boston Pacific Medical, Inc. (Boston, US). The FDA issued a Cleared decision on March 28, 1994, 276 days after receiving the submission on June 25, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K933109 FDA.gov
FDA Decision Cleared SEKD
Date Received June 25, 1993
Decision Date March 28, 1994
Days to Decision 276 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KOD — Catheter, Urological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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