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Klein Rectal Tampnade Balloon

by Cook Urological, Inc. 510(k)

Active United States

510(k) K933842

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK933842 Date29 Sep 1994ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Klein Rectal Tampnade Balloon is a medical device used for rectal tamponade. It is a balloon device designed for this specific purpose.

The device is supplied by Cook Urological, Inc. and has been cleared with the FDA 510(k) number K933842. The device has a product code of KNT and is described as substantially equivalent. It is available with specific sizes, such as 42fr and 14ml, and is used in a clinical setting.

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