510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872214Substantially Equivalent

Cooper Surg Aspiration Cannula/custom Conven Paks

CooperVision, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872214 is the FDA 510(k) clearance record for COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS, a class I device, cleared for CooperVision, Inc. on under FDA product code GEA (Cannula, Surgical, General & Plastic Surgery). FDA records list 97 510(k) clearances for CooperVision, Inc., from to . As of , FDA records show no recalls naming K872214.

Clearance record

Decision date
Received
(69 days to decision)
Product code
GEA Cannula, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
CooperVision, Inc. 17701 Cowan Ave.P. O. Box, Irvine CA
Third party review
No

Clearances, product code GEA

Trailing 12 months

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

FDA records show no clearances under product code GEA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GEA, 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