510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K960287Substantially Equivalent

Handpiece for Nidek Cv-12000 Phaco System

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

K960287 is the FDA 510(k) clearance record for HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM, a class II device, cleared for Nidek, Inc. on under FDA product code HQC (Unit, Phacofragmentation). FDA records list 21 510(k) clearances for Nidek, Inc., from to . As of , FDA records show no recalls naming K960287.

Clearance record

Decision date
Received
(288 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Nidek, Inc. 47651 Westinghouse Dr., Fremont CA
510(k) summary
Statement
Third party review
No

Clearances, product code HQC

Trailing 12 months
3 clearances under product code HQC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260