Cleared Traditional

K102141 - COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)

K102141 is an FDA 510(k) clearance for COOK WORD BARTHOLIN GLAND CATHETER (FIN..., manufactured by Cook Urological, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNA cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K102141 · Cook Urological, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
281d
Days
Class 2
Risk

K102141 is an FDA 510(k) clearance for the COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED). Classified as Instrument, Manual, Specialized Obstetric-gynecologic (product code KNA), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on May 6, 2011 after a review of 281 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Urological, Inc. devices

FDA 510(k) Submission Details - K102141

510(k) Number K102141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2010
Decision Date May 06, 2011
Days to Decision 281 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 160d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNA Device Classification - Class 2, Special Controls

Product Code KNA Instrument, Manual, Specialized Obstetric-gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KNA Instrument, Manual, Specialized Obstetric-gynecologic

All 38
Devices cleared under the same product code (KNA) and FDA review panel - the closest regulatory comparables to K102141.
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
K082939 · Cook Urological, Inc. · Sep 2009
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
K062438 · Cook Ob/Gyn · Oct 2006
TAMPONADE UTERINE BALLOON CATHETER SET
K013597 · Cook Ob/Gyn · Apr 2002
DR. JAHANGER'S CUTTER
K990738 · M.S. Jahanger, MD · Oct 1999
BERACLAMP, MODEL BC-1
K990045 · Poamax LLC · May 1999
SCC-23 SAFETY CLAMP AND CUTTER
K982464 · Women First Healthcare, Inc. · Aug 1998