510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895013Substantially Equivalent

Cobo Temporary Keratoprosthesis

Ocular Instruments, Inc., Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895013 is the FDA 510(k) clearance record for COBO TEMPORARY KERATOPROSTHESIS, a class II device, cleared for Ocular Instruments, Inc. on under FDA product code MLP (Keratoprosthesis, Temporary Implant, Surgical Use). FDA records list 50 510(k) clearances for Ocular Instruments, Inc., from to . As of , FDA records show no recalls naming K895013.

Clearance record

Decision date
Received
(84 days to decision)
Product code
MLP Keratoprosthesis, Temporary Implant, Surgical Use
Regulation
21 CFR 886.3400
Device class
Class II
Review panel
Ophthalmic
Applicant
Ocular Instruments, Inc. 2255 116th Ave., NE, Bellevue WA
Third party review
No

Clearances, product code MLP

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