510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012579Substantially Equivalent

Reprocessed Phaco Tips

Sterilmed Inc, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012579 is the FDA 510(k) clearance record for REPROCESSED PHACO TIPS, a class II device, cleared for Sterilmed, Inc. on under FDA product code NKX (Needle, Phacoemulsification, Reprocessed). FDA's definition for product code NKX reads: "Needle for phacoemulsification device to remove cataractous lens. Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a "reprocessed" needle. The Phacoemulsification device is...". FDA records list 65 510(k) clearances for Sterilmed, Inc., from to . As of , FDA records show one recall naming K012579.

Clearance record

Decision date
Received
(91 days to decision)
Product code
NKX Needle, Phacoemulsification, Reprocessed
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Sterilmed, Inc. 11400 73rd Ave. N Suite 100, Maple Grove MN
510(k) summary
Summary
Third party review
No

Clearances, product code NKX

Trailing 12 months

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

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