510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K924052Substantially Equivalent

Infinity Micro Irrigator

Infinity Surgical Technology, Inc., Northbrook IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924052 is the FDA 510(k) clearance record for INFINITY MICRO IRRIGATOR, a class I device, cleared for Infinity Surgical Technology, Inc. on under FDA product code KYG (Device, Irrigation, Ocular Surgery). FDA records list one 510(k) clearance for Infinity Surgical Technology, Inc. As of , FDA records show no recalls naming K924052.

Clearance record

Decision date
Received
(133 days to decision)
Product code
KYG Device, Irrigation, Ocular Surgery
Regulation
21 CFR 886.4360
Device class
Class I
Review panel
Ophthalmic
Applicant
Infinity Surgical Technology, Inc. 3174 Doolittle Dr., Northbrook IL
510(k) summary
Statement
Third party review
No

Clearances, product code KYG

Trailing 12 months

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

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