510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K861141Substantially Equivalent

Manual Ophthalmic Surgical Instruments

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

K861141 is the FDA 510(k) clearance record for MANUAL OPHTHALMIC SURGICAL INSTRUMENTS, a class I device, cleared for CooperVision, Inc. on under FDA product code HNR (Forceps, Ophthalmic). FDA records list 97 510(k) clearances for CooperVision, Inc., from to . As of , FDA records show no recalls naming K861141.

Clearance record

Decision date
Received
(29 days to decision)
Product code
HNR Forceps, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
CooperVision, Inc. Coopervision Cilco, Bellevue WA
Third party review
No

Clearances, product code HNR

Trailing 12 months

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

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