Cleared Traditional

K013597 - TAMPONADE UTERINE BALLOON CATHETER SET

K013597 is the FDA 510(k) clearance for TAMPONADE UTERINE BALLOON CATHETER SET by Cook Ob/Gyn. It is a Class 2 Obstetrics & Gynecology device (product code KNA) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K013597 · Cook Ob/Gyn · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
168d
Days
Class 2
Risk

K013597 is an FDA 510(k) clearance for the TAMPONADE UTERINE BALLOON CATHETER SET. Classified as Instrument, Manual, Specialized Obstetric-gynecologic (product code KNA), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on April 17, 2002 after a review of 168 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 Ob/Gyn devices

Submission Details

510(k) Number K013597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2001
Decision Date April 17, 2002
Days to Decision 168 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
8d slower than avg
Panel avg: 160d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 19
Devices cleared under the same product code (KNA) and FDA review panel - the closest regulatory comparables to K013597.
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
K102141 · Cook Urological, Inc. · May 2011
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
BALLOON UTERINE STENT
K952527 · Cook Urological, Inc. · Jan 1996
CORDGUARD II
K954619 · Utah Medical Products, Inc. · Dec 1995
RETRACTOR RODS
K891398 · Zinnanti Surgical Instruments, Inc. · May 1989