Cleared Traditional

K902563 - MONOSCOPY(TM) BRAND, TROCAR REDUCER SET

K902563 is an FDA 510(k) clearance for MONOSCOPY(TM) BRAND, manufactured by Dexide, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K902563 · Dexide, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Sep 1990
Decision
85d
Days
Class 2
Risk

K902563 is an FDA 510(k) clearance for the MONOSCOPY(TM) BRAND, TROCAR REDUCER SET. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Dexide, Inc. (Fort Worth, US). The FDA issued a Cleared decision on September 4, 1990 after a review of 85 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 - K902563

510(k) Number K902563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1990
Decision Date September 04, 1990
Days to Decision 85 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
76d faster than avg
Panel avg: 161d · This submission: 85d
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 K902563.
ESPI NON-INSULATED DOUBLE-ACTION GRASPER #8204
K903601 · Dixon Medical, Inc. · Sep 1990
ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203
K903602 · Dixon Medical, Inc. · Sep 1990
SPIRTOS COAXIAL CATHETER SET
K896524 · Cook Ob/Gyn · Sep 1990
LAPAROSCOPE
K903528 · Intramed Laboratories, Inc. · Sep 1990
GYNESCOPE LAPAROSCOPES
K902655 · Gynescope Corp. · Jul 1990
GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES
K902656 · Gynescope Corp. · Jun 1990
K902563 · MONOSCOPY(TM) BRAND, TROCAR REDUCER SET
Download PDF Dexide, Inc.