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
K832912Substantially Equivalent

Gelender Vacuum Fixation Ring Sys

Miami Eye Technology, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832912 is the FDA 510(k) clearance record for GELENDER VACUUM FIXATION RING SYS, a class I device, cleared for Miami Eye Technology, Inc. on under FDA product code HNH (Ring, Ophthalmic (Flieringa)). FDA records list 6 510(k) clearances for Miami Eye Technology, Inc., from to . As of , FDA records show no recalls naming K832912.

Clearance record

Decision date
Received
(134 days to decision)
Product code
HNH Ring, Ophthalmic (Flieringa)
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Miami Eye Technology, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HNH

Trailing 12 months

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

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