510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K944818Substantially Equivalent

Cook Aspiration/irrigation Unit

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

K944818 is the FDA 510(k) clearance record for COOK ASPIRATION/IRRIGATION UNIT, a class II device, cleared for Cook Urological, Inc. on under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K944818.

Clearance record

Decision date
Received
(40 days to decision)
Product code
BTA Pump, Portable, Aspiration (Manual Or Powered)
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
510(k) summary
Summary
Third party review
No

Clearances, product code BTA

Trailing 12 months
7 clearances under product code BTA in the twelve months to November 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code BTA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20261
May 20264
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260