Cleared Traditional

K843158 - SEXTON CYSTOTOMY URINE PUMP

K843158 is an FDA 510(k) clearance for SEXTON CYSTOTOMY URINE PUMP, manufactured by Holter-Hausner Intl.. The device is a Class 2 Gastroenterology & Urology device with product code KOB cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K843158 · Holter-Hausner Intl. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
55d
Days
Class 2
Risk

K843158 is an FDA 510(k) clearance for the SEXTON CYSTOTOMY URINE PUMP. Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Holter-Hausner Intl. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1984 after a review of 55 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 Holter-Hausner Intl. devices

FDA 510(k) Submission Details - K843158

510(k) Number K843158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1984
Decision Date October 04, 1984
Days to Decision 55 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
75d faster than avg
Panel avg: 130d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOB Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K843158.
(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET
K863120 · Cook Urological, Inc. · Oct 1986
VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS
K863386 · Angiomed U.S., Inc. · Oct 1986
PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET
K852287 · Cook Ob/Gyn · Aug 1985
CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET
K813084 · Burron Medical Products, Inc. · Dec 1981
SUPRAPUBIC TROCAR
K800607 · G.D. Searle and Co. · Apr 1980