Cleared Traditional

K883119 - VPI NON-ADHESIVE CONDOM CATHETER
(FDA 510(k) Clearance)

K883119 · Cook Urological, Inc. · Gastroenterology & Urology
Aug 1988
Decision
8d
Days
Class 1
Risk

K883119 is an FDA 510(k) clearance for the VPI NON-ADHESIVE CONDOM CATHETER. This device is classified as a Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile (Class I — General Controls, product code EYT).

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on August 2, 1988, 8 days after receiving the submission on July 25, 1988.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K883119 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1988
Decision Date August 02, 1988
Days to Decision 8 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

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