510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K880968Substantially Equivalent

Model 2001 Phacoemulsifier Aspirator

Mcghan Instrumed Corp., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880968 is the FDA 510(k) clearance record for MODEL 2001 PHACOEMULSIFIER ASPIRATOR, a class II device, cleared for Mcghan Instrumed Corp. on under FDA product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered). FDA records list one 510(k) clearance for Mcghan Instrumed Corp. As of , FDA records show no recalls naming K880968.

Clearance record

Decision date
Received
(42 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
Mcghan Instrumed Corp. 3597 E. Supernal Cir., Salt Lake City UT
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