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
K912576Substantially Equivalent

Instrument Wipe and Corneal Shield

Katena Products, Inc., Denville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912576 is the FDA 510(k) clearance record for INSTRUMENT WIPE AND CORNEAL SHIELD, a class I device, cleared for Katena Products, Inc. on under FDA product code HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)). FDA records list 3 510(k) clearances for Katena Products, Inc., from to . As of , FDA records show no recalls naming K912576.

Clearance record

Decision date
Received
(233 days to decision)
Product code
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Regulation
21 CFR 886.4750
Device class
Class I
Review panel
Ophthalmic
Applicant
Katena Products, Inc. 4 Stewart Ct., Denville NJ
510(k) summary
Statement
Third party review
No

Clearances, product code HOY

Trailing 12 months

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

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