Cleared Traditional

K902417 - BAG

K902417 is the FDA 510(k) clearance for BAG by Gainor Medical Europe, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K902417 · Gainor Medical Europe, Ltd. · Gastroenterology & Urology device
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Jul 1990
Decision
46d
Days
Class 2
Risk

K902417 is an FDA 510(k) clearance for the BAG, URINE. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Gainor Medical Europe, Ltd. (Mcdonough, US). The FDA issued a Cleared decision on July 16, 1990 after a review of 46 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 Gainor Medical Europe, Ltd. devices

Submission Details

510(k) Number K902417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1990
Decision Date July 16, 1990
Days to Decision 46 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 130d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 41
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K902417.
PROSYS LEG BAG
K952208 · Convatec, A Division of E.R. Squibb & Sons · Aug 1995
BARD URINE COLLECTION PRODUCTS MODIFICATION
K940206 · C.R. Bard, Inc. · Sep 1994
HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878
K926570 · Hollister, Inc. · May 1993
URINE COLLECTOR LEG BAG
K896688 · Medline Industries, Inc. · May 1990
SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP
K881678 · Hollister, Inc. · Aug 1988
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
K871610 · Coloplast A/S · Jun 1987