Cleared Traditional

K871643 - CONVEEN(R) LEG-BAG (600 ML)

K871643 is an FDA 510(k) clearance for CONVEEN LEG-BAG (600 ML), manufactured by Coloplast A/S. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K871643 · Coloplast A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
44d
Days
Class 2
Risk

K871643 is an FDA 510(k) clearance for the CONVEEN(R) LEG-BAG (600 ML). Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on June 10, 1987 after a review of 44 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 A/S devices

FDA 510(k) Submission Details - K871643

510(k) Number K871643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1987
Decision Date June 10, 1987
Days to Decision 44 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 130d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNX Device Classification - Class 2, Special Controls

Product Code KNX Collector, Urine, (and Accessories) For Indwelling Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNX Collector, Urine, (and Accessories) For Indwelling Catheter

All 94
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K871643.
SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP
K881678 · Hollister, Inc. · Aug 1988
URETHAL CATHETER
K874309 · Medovations, Inc. · Dec 1987
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
K871610 · Coloplast A/S · Jun 1987
NORTA (TM) UROBAG
K870504 · Beiersdorf, Inc. · Apr 1987
HOLLISTER FEMALE URINARY COLLECTION POUCH
K862934 · Hollister, Inc. · Aug 1986
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
K860362 · Travenol Laboratories, S.A. · Apr 1986