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Medscand Endorette Endometrial Sampler

by Medscand (Usa), Inc.

510(k) K952652

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952652 Date15 Sep 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HHK
Device Class
Class II
Regulation
21 CFR Part 884.1175
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Medscand Endorette Endometrial Sampler is a curette, suction, endometrial device and accessories, classified as a Class II medical device under regulation number 884.1175. It is designed for obtaining histological material from the uterus, featuring a closed blunt tip and four side openings to facilitate insertion without the need for prior dilation, with a built-in suction shank providing ideal negative pressure for gentle sample collection.

The device is supplied in a package of 25 units (BX/25) and is intended for use in obstetrics and gynecology settings. It is a single-use device, as indicated by its design and typical clinical application, and has received FDA 510(k) clearance under K952652, with the product code HHK and applicant Medscand (Usa), Inc. No information regarding sterility, MRI safety, storage conditions, or reusability is provided in the data.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Medscand Endorette Endometrial Sampler used for?

    It is designed for obtaining histological material from the uterus in obstetrics and gynecology settings, featuring a closed blunt tip and four side openings to facilitate insertion without prior dilation and a built-in suction shank for gentle sample collection.

  • How is the Medscand Endorette Endometrial Sampler supplied and is it reusable?

    The device is supplied in a package of 25 units (BX/25) and is intended for single-use only, as indicated by its design and typical clinical application, with no information provided about reusability or reprocessing.

  • Does the Medscand Endorette Endometrial Sampler require cervical dilation before use?

    No, the device features a closed blunt tip and four side openings that facilitate insertion without the need for prior dilation, allowing for direct uterine access during endometrial sampling procedures.