Cleared Traditional

K863386 - VESICO SUPRAPUBIC BLADDER DRAINAGE & EX...

K863386 is the FDA 510(k) clearance for VESICO SUPRAPUBIC BLADDER DRAINAGE & EX... by Angiomed U.S., Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOB) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K863386 · Angiomed U.S., Inc. · Gastroenterology & Urology device
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Oct 1986
Decision
51d
Days
Class 2
Risk

K863386 is an FDA 510(k) clearance for the VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS. Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on October 24, 1986 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - 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 Angiomed U.S., Inc. devices

Submission Details

510(k) Number K863386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date October 24, 1986
Days to Decision 51 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
79d faster than avg
Panel avg: 130d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOB Catheter, Suprapubic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
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 - KOB Catheter, Suprapubic (and Accessories)

All 15
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K863386.
VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET
K870555 · Van-Tec, Inc. · Mar 1987
VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET
K870556 · Van-Tec, Inc. · Mar 1987
(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET
K863120 · Cook Urological, Inc. · Oct 1986
PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET
K852287 · Cook Ob/Gyn · Aug 1985
SEXTON CYSTOTOMY URINE PUMP
K843158 · Holter-Hausner Intl. · Oct 1984
CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET
K813084 · Burron Medical Products, Inc. · Dec 1981