Cleared Traditional

K883057 - COMFORT CATH MALE EXTERNAL CATHETER
(FDA 510(k) Clearance)

K883057 · Sierra Laboratories, Inc. · Gastroenterology & Urology
Aug 1988
Decision
14d
Days
Class 1
Risk

K883057 is an FDA 510(k) clearance for the COMFORT CATH MALE EXTERNAL CATHETER. This device is classified as a Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile (Class I — General Controls, product code EYT).

Submitted by Sierra Laboratories, Inc. (Tucson, US). The FDA issued a Cleared decision on August 2, 1988, 14 days after receiving the submission on July 19, 1988.

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

Submission Details

510(k) Number K883057 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1988
Decision Date August 02, 1988
Days to Decision 14 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