Cleared Traditional

K955609 - CONVEEN URINE BAG - STERILE

K955609 is the FDA 510(k) clearance for CONVEEN URINE BAG - STERILE by Coloplast Corp.. It is a Class 1 Gastroenterology & Urology device (product code FAQ) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K955609 · Coloplast Corp. · Gastroenterology & Urology device
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Dec 1995
Decision
21d
Days
Class 1
Risk

K955609 is an FDA 510(k) clearance for the CONVEEN URINE BAG - STERILE. Classified as Bag, Urine Collection, Leg, For External Use, Sterile (product code FAQ), Class I - General Controls.

Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on December 29, 1995 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coloplast Corp. devices

Submission Details

510(k) Number K955609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1995
Decision Date December 29, 1995
Days to Decision 21 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 130d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FAQ Bag, Urine Collection, Leg, For External Use, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FAQ Bag, Urine Collection, Leg, For External Use, Sterile

All 8
Devices cleared under the same product code (FAQ) and FDA review panel - the closest regulatory comparables to K955609.
PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
K962604 · Convatec, A Division of E.R. Squibb & Sons · Jul 1996
PROSYS BEDSIDE DRAINAGE BAG
K953767 · Convatec, A Division of E.R. Squibb & Sons · Dec 1995
CONVEEN LEG BAG STRAP
K953783 · Coloplast Corp. · Sep 1995
PROSYS LEG BAG
K951945 · Convatec, A Division of E.R. Squibb & Sons · May 1995
BARD LEG BAG HOLDER
K926035 · C.R. Bard, Inc. · Dec 1992
CONVEEN(R) LEG BAG(500 ML)
K924406 · Coloplast A/S · Oct 1992