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
K926412Substantially Equivalent

Micron-Scope II

Chiron Vision Corp., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926412 is the FDA 510(k) clearance record for MICRON-SCOPE II, a class I device, cleared for Chiron Vision Corp. on under FDA product code HMS (Drum, Eye Knife Test). FDA records list 34 510(k) clearances for Chiron Vision Corp., from to . As of , FDA records show no recalls naming K926412.

Clearance record

Decision date
Received
(575 days to decision)
Product code
HMS Drum, Eye Knife Test
Regulation
21 CFR 886.4230
Device class
Class I
Review panel
Ophthalmic
Applicant
Chiron Vision Corp. 9342 Jeronimo Rd., Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code HMS

Trailing 12 months

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

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