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Therapeutic Apparatus, Dierker Type

by Well Being Ent.

510(k) K770534

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 NumberK770534 Date21 Apr 1978ClearedStatusActive

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  • Withdrawn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
KDH
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Therapeutic Apparatus, Dierker Type is a medical device classified as a catheter for gastric, colonic, and other applications, used for irrigation and aspiration. It is intended for use in gastroenterology and urology procedures.

This device is supplied by Well Being Ent. and has FDA 510(k) clearance with the product code KDH. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.

Questions

AI-generated answers, 28 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 Therapeutic Apparatus Dierker Type used for?

    The Therapeutic Apparatus Dierker Type is a catheter designed for gastric, colonic, and other applications, specifically used for irrigation and aspiration procedures in gastroenterology and urology.

  • Is the Therapeutic Apparatus Dierker Type single-use or reusable?

    The device data does not specify whether the Therapeutic Apparatus Dierker Type is intended for single-use or reusable purposes. No information regarding sterility or reuse is provided in the available documentation.

  • What regulatory clearance does the Therapeutic Apparatus Dierker Type have?

    The Therapeutic Apparatus Dierker Type has FDA 510(k) clearance with product code KDH, classified as a Class II device for catheters used in gastric, colonic, and other applications for irrigation and aspiration.

  • What are the specifications of the Therapeutic Apparatus Dierker Type?

    The device is classified as a catheter for gastric, colonic, and other applications, used for irrigation and aspiration. It is intended for gastroenterology and urology procedures and has been determined to be substantially equivalent to predicate devices.