510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K161002Substantially Equivalent

Aprima Smartesis Centesis Pump

Cook Incorporated, Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161002 is the FDA 510(k) clearance record for Aprima Smartesis Centesis Pump, a class II device, cleared for Cook Incorporated 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 K161002.

Clearance record

Decision date
Received
(170 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 Incorporated 750 Daniels Way, Bloomington IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTA

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