Cleared Traditional

K120127 - SWAN VALLEY MEDICAL TRANURETHRAL SUPRAP...

K120127 is an FDA 510(k) clearance for SWAN VALLEY MEDICAL TRANURETHRAL SUPRAP..., manufactured by Swan Valley Medical, Incorporated. The device is a Class 2 Gastroenterology & Urology device with product code KOB cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K120127 · Swan Valley Medical, Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
283d
Days
Class 2
Risk

K120127 is an FDA 510(k) clearance for the SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL.... Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Swan Valley Medical, Incorporated (Golden, US). The FDA issued a Cleared decision on October 26, 2012 after a review of 283 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Swan Valley Medical, Incorporated devices

FDA 510(k) Submission Details - K120127

510(k) Number K120127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2012
Decision Date October 26, 2012
Days to Decision 283 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 130d · This submission: 283d
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 15
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K120127.
Cook Cystostomy Catheter Set
K181097 · Cook Incorporated · Jan 2019
One-Step Suprapubic Introducer
K182709 · Cook Incorporated · Dec 2018
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
K182066 · Cook Incorporated · Oct 2018
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
K970969 · The Kendal Co. · Apr 1997
LINDNER/GOLOMB SP INTRODUCING SOUND
K953024 · Cook Urological, Inc. · Aug 1995
SUPRAPUBIC FLOW CONTROLLER
K904798 · Olympus Corp. · Nov 1991