510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022843Substantially Equivalent

Gayheart Corneal Excision Device

Stephens Instruments, Inc, Lexington KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022843 is the FDA 510(k) clearance record for GAYHEART CORNEAL EXCISION DEVICE, a class I device, cleared for Stephens Instruments on under FDA product code HRH (Trephine, Manual, Ophthalmic). FDA records list 5 510(k) clearances for Stephens Instruments. As of , FDA records show no recalls naming K022843.

Clearance record

Decision date
Received
(66 days to decision)
Product code
HRH Trephine, Manual, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Stephens Instruments 2500 Sandersville Rd., Lexington KY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRH

Trailing 12 months

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

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