Cleared Traditional

K896524 - SPIRTOS COAXIAL CATHETER SET

K896524 is an FDA 510(k) clearance for SPIRTOS COAXIAL CATHETER SET, manufactured by Cook Ob/Gyn. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K896524 · Cook Ob/Gyn · Obstetrics & Gynecology device
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Sep 1990
Decision
294d
Days
Class 2
Risk

K896524 is an FDA 510(k) clearance for the SPIRTOS COAXIAL CATHETER SET. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on September 5, 1990 after a review of 294 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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

FDA 510(k) Submission Details - K896524

510(k) Number K896524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1989
Decision Date September 05, 1990
Days to Decision 294 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 160d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 225
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K896524.
LAPAROSCOPIC CATHERTER
K903187 · Cook Ob/Gyn · Oct 1990
AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE
K903207 · United States Surgical, A Division of Tyco Healthc · Sep 1990
5 MM IRRIGATION/ASPIRATION FIBER PROBE
K902258 · Hgm Medical Laser Systems, Inc. · Sep 1990
MONOSCOPY(TM) BRAND, TROCAR REDUCER SET
K902563 · Dexide, Inc. · Sep 1990
CORE DISPOSABLE TROCARS
K901407 · Core Dynamics, Inc. · Jun 1990
AMCATH SUCTION-IRRIGATION TUBE
K900988 · Intl. Medical, Inc. · May 1990