510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K933842Substantially Equivalent

Klein Rectal Tampnade Balloon

Cook Incorporated, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933842 is the FDA 510(k) clearance record for KLEIN RECTAL TAMPNADE BALLOON, a class II device, cleared for Cook Urological, Inc. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K933842.

Clearance record

Decision date
Received
(419 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
510(k) summary
Summary
Third party review
No

Clearances, product code KNT

Trailing 12 months
3 clearances under product code KNT in the twelve months to November 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20261
October 20260
November 20260