510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842197Substantially Equivalent

American Medical Optics I/a Kit- Irrig

American Medical Optics, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842197 is the FDA 510(k) clearance record for AMERICAN MEDICAL OPTICS I/A KIT- IRRIG, a class II device, cleared for American Medical Optics on under FDA product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered). FDA records list 17 510(k) clearances for American Medical Optics, from to . As of , FDA records show no recalls naming K842197.

Clearance record

Decision date
Received
(119 days to decision)
Product code
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Regulation
21 CFR 886.4150
Device class
Class II
Review panel
Ophthalmic
Applicant
American Medical Optics 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HQE

Trailing 12 months

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

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