510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203586Substantially Equivalent

EndoSerter-PL

CorneaGen, Winston-Salem NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203586 is the FDA 510(k) clearance record for EndoSerter-PL, a class I device, cleared for Corneagen, Inc. on under FDA product code OTZ (Graft Insertion Instrument For Endothelial Keratoplasty). FDA's definition for product code OTZ reads: "A graft insertion device for endothelial keratoplasty is a device intended to be inserted into the eye during surgery to direct the insertion of a corneal graft and be removed after insertion is completed". FDA records list one 510(k) clearance for Corneagen, Inc. As of , FDA records show no recalls naming K203586.

Clearance record

Decision date
Received
(421 days to decision)
Product code
OTZ Graft Insertion Instrument For Endothelial Keratoplasty
Regulation
21 CFR 886.4300
Device class
Class I
Review panel
Ophthalmic
Applicant
Corneagen, Inc. 101 N. Chestnut St., Winston-Salem NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OTZ

Trailing 12 months

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

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