Cleared Traditional

URINARY DRAINAGE BAG

K934080 · Kit Pak, Inc. · Gastroenterology & Urology
May 1994
Decision
271d
Days
Class 1
Risk

About This 510(k) Submission

K934080 is an FDA 510(k) clearance for the URINARY DRAINAGE BAG, a Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile (Class I — General Controls, product code EYT), submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on May 18, 1994, 271 days after receiving the submission on August 20, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K934080 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1993
Decision Date May 18, 1994
Days to Decision 271 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code EYT — Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.5250