Cleared Traditional

K895225 - GYNECOLOGICAL INSTRUMENTATION

K895225 is an FDA 510(k) clearance for GYNECOLOGICAL INSTRUMENTATION, manufactured by Gynescope Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K895225 · Gynescope Corp. · Obstetrics & Gynecology device
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Mar 1990
Decision
203d
Days
Class 2
Risk

K895225 is an FDA 510(k) clearance for the GYNECOLOGICAL INSTRUMENTATION. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Gynescope Corp. (Willoughby, US). The FDA issued a Cleared decision on March 5, 1990 after a review of 203 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 Gynescope Corp. devices

FDA 510(k) Submission Details - K895225

510(k) Number K895225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1989
Decision Date March 05, 1990
Days to Decision 203 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 160d · This submission: 203d
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 228
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K895225.
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
LAPAROSCOPIC ACCESS SHEATH SET
K897064 · Cook Ob/Gyn · Feb 1990
ETHICON DISPOSABLE SURGICAL TROCAR
K893715 · Ethicon, Inc. · Aug 1989
NEZHAT IRRIGATION PUMP SYSTEM
K880763 · Cabot Medical Corp. · May 1988