Cleared Traditional

K852287 - PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHET...

K852287 is the FDA 510(k) clearance for PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHET... by Cook Ob/Gyn. It is a Class 2 Gastroenterology & Urology device (product code KOB) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K852287 · Cook Ob/Gyn · Gastroenterology & Urology device
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Aug 1985
Decision
71d
Days
Class 2
Risk

K852287 is an FDA 510(k) clearance for the PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET. Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Bloomington, US). The FDA issued a Cleared decision on August 8, 1985 after a review of 71 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 Cook Ob/Gyn devices

Submission Details

510(k) Number K852287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date August 08, 1985
Days to Decision 71 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
59d faster than avg
Panel avg: 130d · This submission: 71d
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 14
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K852287.
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
SEXTON CYSTOTOMY URINE PUMP
K843158 · Holter-Hausner Intl. · Oct 1984
CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET
K813084 · Burron Medical Products, Inc. · Dec 1981
SUPRAPUBIC TROCAR
K800607 · G.D. Searle and Co. · Apr 1980