Cleared Traditional

K897064 - LAPAROSCOPIC ACCESS SHEATH SET

K897064 is an FDA 510(k) clearance for LAPAROSCOPIC ACCESS SHEATH 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 48-day FDA review.

K897064 · Cook Ob/Gyn · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Feb 1990
Decision
48d
Days
Class 2
Risk

K897064 is an FDA 510(k) clearance for the LAPAROSCOPIC ACCESS SHEATH 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 February 6, 1990 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K897064

510(k) Number K897064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1989
Decision Date February 06, 1990
Days to Decision 48 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
113d faster than avg
Panel avg: 161d · This submission: 48d
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 337
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K897064.
AMCATH SUCTION-IRRIGATION TUBE
K900988 · Intl. Medical, Inc. · May 1990
NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE
K896118 · American Surgical Instruments Corp. · Mar 1990
GYNECOLOGICAL INSTRUMENTATION
K895225 · Gynescope Corp. · Mar 1990
ETHICON DISPOSABLE SURGICAL TROCAR
K893715 · Ethicon, Inc. · Aug 1989
OPTI-POINT
K884781 · Plastic Injectors, Inc. · Jan 1989
TITANIUM BACKSTOP WITH SUCTION
K874611 · Medical Marketing, Inc. · Jun 1988
K897064 · LAPAROSCOPIC ACCESS SHEATH SET
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