510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980647Substantially Equivalent

Eye Irrigator Model #2020

Eye-Deal Ocular Safety Products, Inc., Stillwater MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980647 is the FDA 510(k) clearance record for EYE IRRIGATOR MODEL #2020, a class I device, cleared for Eye-Deal Ocular Safety Products, Inc. on under FDA product code KYG (Device, Irrigation, Ocular Surgery). FDA records list one 510(k) clearance for Eye-Deal Ocular Safety Products, Inc. As of , FDA records show no recalls naming K980647.

Clearance record

Decision date
Received
(87 days to decision)
Product code
KYG Device, Irrigation, Ocular Surgery
Regulation
21 CFR 886.4360
Device class
Class I
Review panel
Ophthalmic
Applicant
Eye-Deal Ocular Safety Products, Inc. P.O. Box 560, Stillwater MN
510(k) summary
Summary
Third party review
No

Clearances, product code KYG

Trailing 12 months

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

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