510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881095Substantially Equivalent

Koi(tm) Instrument Trays

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

K881095 is the FDA 510(k) clearance record for KOI(TM) INSTRUMENT TRAYS, a class I device, cleared for CooperVision, Inc. on under FDA product code LRP (Tray, Surgical). FDA records list 97 510(k) clearances for CooperVision, Inc., from to . As of , FDA records show no recalls naming K881095.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LRP Tray, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
CooperVision, Inc. Coopervision Cilco, Bellevue WA
Third party review
No

Clearances, product code LRP

Trailing 12 months

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

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