510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833747Substantially Equivalent

Gallie Cryonucleator

Mono Research Laboratories, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833747 is the FDA 510(k) clearance record for GALLIE CRYONUCLEATOR, a class II device, cleared for Mono Research Laboratories on under FDA product code HPS (Unit, Cryophthalmic). FDA records list one 510(k) clearance for Mono Research Laboratories. As of , FDA records show no recalls naming K833747.

Clearance record

Decision date
Received
(196 days to decision)
Product code
HPS Unit, Cryophthalmic
Regulation
21 CFR 886.4170
Device class
Class II
Review panel
Ophthalmic
Applicant
Mono Research Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HPS

Trailing 12 months

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

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