Cleared Traditional

K082939 - COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400

K082939 is an FDA 510(k) clearance for COOK FETAL MEMBRANE MANIPULATOR, 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 336-day FDA review.

K082939 · Cook Urological, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
336d
Days
Class 2
Risk

K082939 is an FDA 510(k) clearance for the COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400. Classified as Instrument, Manual, Specialized Obstetric-gynecologic (product code KNA), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Bloomington, US). The FDA issued a Cleared decision on September 3, 2009 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K082939

510(k) Number K082939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2008
Decision Date September 03, 2009
Days to Decision 336 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
176d slower than avg
Panel avg: 160d · This submission: 336d
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 K082939.
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
K102141 · Cook Urological, Inc. · May 2011
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