510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K884291Substantially Equivalent

Cook Hysterocath(tm)

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

K884291 is the FDA 510(k) clearance record for COOK HYSTEROCATH(TM), a class II device, cleared for Cook, Inc. on under FDA product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic). FDA records list 163 510(k) clearances for Cook, Inc., from to . As of , FDA records show no recalls naming K884291.

Clearance record

Decision date
Received
(57 days to decision)
Product code
KNA Instrument, Manual, Specialized Obstetric-Gynecologic
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Cook, Inc. 925 S. Curry Pike, Bloomington IN
Third party review
No

Clearances, product code KNA

Trailing 12 months

FDA records hold no clearances under product code KNA in the trailing twelve months.

FDA records show no clearances under product code KNA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260