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FDA 510(k)

REPROCESSED PHACO TIPS

K-Number: K012579 · 2001-11-08

ApplicantSterilmed, Inc.
Decision Date2001-11-08
Product CodeNKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

REPROCESSED PHACO TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2001-11-08 under 510(k) number K012579. The device is classified under product code NKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED PHACO TIPS?

REPROCESSED PHACO TIPS is a medical device that received FDA 510(k) clearance on 2001-11-08. The listed applicant is Sterilmed, Inc.. The 510(k) number is K012579.

When did REPROCESSED PHACO TIPS receive FDA 510(k) clearance?

REPROCESSED PHACO TIPS received FDA 510(k) clearance on 2001-11-08, under 510(k) number K012579.

Who is the listed applicant for REPROCESSED PHACO TIPS?

The FDA 510(k) record lists Sterilmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED PHACO TIPS?

The FDA product code for REPROCESSED PHACO TIPS is NKX.

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Related Devices (Code: NKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K060648REPROCESSED PHACOEMULSIFICATION TIPSAlliance Medical Corp.K050518REPROCESSED PHACOEMUISIFICATION TIPSAlliance Medical, Inc.K030179MEDISISS PHACOEMULSIFICATION TIPS/NEEDLESSurgical Instruments Service and Savings, Inc.K012698VANGUARD REPROCESSED PHACOEMULSIFICATIONVanguard Medical Concepts, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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