Cleared Traditional

K860362 - SILICATH-AG SILICONE ELASTOMER FOLEY CA...

K860362 is the FDA 510(k) clearance for SILICATH-AG SILICONE ELASTOMER FOLEY CA... by Travenol Laboratories, S.A.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K860362 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Apr 1986
Decision
89d
Days
Class 2
Risk

K860362 is an FDA 510(k) clearance for the SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on April 29, 1986 after a review of 89 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K860362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1986
Decision Date April 29, 1986
Days to Decision 89 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
41d faster than avg
Panel avg: 130d · This submission: 89d
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 64
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K860362.
CONVEEN(R) LEG-BAG (600 ML)
K871643 · Coloplast A/S · Jun 1987
NORTA (TM) UROBAG
K870504 · Beiersdorf, Inc. · Apr 1987
HOLLISTER FEMALE URINARY COLLECTION POUCH
K862934 · Hollister, Inc. · Aug 1986
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
K854580 · Coloplast A/S · Dec 1985
H-H SEXTON SCUP URINE MGMT. SYS
K853458 · Holter-Hausner Intl. · Aug 1985
KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG
K852085 · The Kendal Co. · Aug 1985