Cleared Traditional

K952652 - MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER

K952652 is an FDA 510(k) clearance for MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER, manufactured by Medscand (Usa), Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHK cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K952652 · Medscand (Usa), Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
98d
Days
Class 2
Risk

K952652 is an FDA 510(k) clearance for the MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Medscand (Usa), Inc. (Hollywood, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 98 days - within the typical 510(k) review window.

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 Medscand (Usa), Inc. devices

FDA 510(k) Submission Details - K952652

510(k) Number K952652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1995
Decision Date September 15, 1995
Days to Decision 98 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 160d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHK Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K952652.
ENDOMETRIAL SAMPLER
K990387 · U.A. Medical Products, Inc. · Apr 1999
SELECTCELLS(TM) MINI
K974819 · Select Medical Systems, Inc. · Mar 1998
CPR D & C TRAY
K960239 · Custom Pack Reliability · May 1996
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