Cleared Traditional

K853216 - MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3

K853216 is the FDA 510(k) clearance for MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3 by Gyneco, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HHK) cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K853216 · Gyneco, Inc. · Obstetrics & Gynecology device
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Apr 1986
Decision
244d
Days
Class 2
Risk

K853216 is an FDA 510(k) clearance for the MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Gyneco, Inc. (Somerville, US). The FDA issued a Cleared decision on April 2, 1986 after a review of 244 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1175 - 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 Gyneco, Inc. devices

Submission Details

510(k) Number K853216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1985
Decision Date April 02, 1986
Days to Decision 244 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
84d slower than avg
Panel avg: 160d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHK Curette, Suction, Endometrial (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1175
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 - HHK Curette, Suction, Endometrial (and Accessories)

All 14
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K853216.
FOWLER ENDOCURETTE, MODEL CUR-XXX
K000974 · Utah Medical Products, Inc. · May 2000
CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE
K875084 · Cabot Medical Corp. · Feb 1988
ENDOMETRIAL SAMPLER
K872908 · Zinnanti Surgical Instruments, Inc. · Oct 1987
U.V.A.C. HANDLER SET
K822382 · American Hospital Supply Corp. · Aug 1982
SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES
K801070 · Sherwood Medical Industries · Jul 1980
MASTERSON* ENDOMETRIAL BIOPSY KIT
K791765 · Codman & Shurtleff, Inc. · Nov 1979