Cleared Traditional

K873177 - DEVINE (SUPRAPUBIC SOUND AND GUIDE)

K873177 is an FDA 510(k) clearance for DEVINE (SUPRAPUBIC SOUND AND GUIDE), manufactured by Penn Medical Devices, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOE cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K873177 · Penn Medical Devices, Inc. · Gastroenterology & Urology device
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Oct 1987
Decision
63d
Days
Class 2
Risk

K873177 is an FDA 510(k) clearance for the DEVINE (SUPRAPUBIC SOUND AND GUIDE). Classified as Dilator, Urethral (product code KOE), Class II - Special Controls.

Submitted by Penn Medical Devices, Inc. (Basking Ridge, US). The FDA issued a Cleared decision on October 14, 1987 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5520 - 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 Penn Medical Devices, Inc. devices

FDA 510(k) Submission Details - K873177

510(k) Number K873177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1987
Decision Date October 14, 1987
Days to Decision 63 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
67d faster than avg
Panel avg: 130d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOE Device Classification - Class 2, Special Controls

Product Code KOE Dilator, Urethral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5520
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 - KOE Dilator, Urethral

All 15
Devices cleared under the same product code (KOE) and FDA review panel - the closest regulatory comparables to K873177.
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
K900761 · American Medical Systems, Inc. · May 1990
URETHRAL BALLOON DILATION CATHETER SET
K892855 · Cook Urological, Inc. · Nov 1989
PROSTATIC URETHRO. BALLOON DILATATION CATHETER
K873295 · Medi-Tech, Inc. · Jul 1989
VAN-TEC URETHRAL DILATATION SYSTEM
K870695 · Van-Tec, Inc. · Mar 1987
VAN-TEC MEATAL DILATOR
K851158 · Van-Tec, Inc. · Apr 1985
KOLLMANN URETHRAL DILATOR
K841386 · Imm Enterprises , Ltd. · May 1984