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FDA 510(k)

MILLENNIUM MICROSURGICAL SYSTEM

K-Number: K022760 · 2002-11-18

ApplicantBausch & Lomb, Inc.
Decision Date2002-11-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MILLENNIUM MICROSURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2002-11-18 under 510(k) number K022760. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILLENNIUM MICROSURGICAL SYSTEM?

MILLENNIUM MICROSURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2002-11-18. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K022760.

When did MILLENNIUM MICROSURGICAL SYSTEM receive FDA 510(k) clearance?

MILLENNIUM MICROSURGICAL SYSTEM received FDA 510(k) clearance on 2002-11-18, under 510(k) number K022760.

Who is the listed applicant for MILLENNIUM MICROSURGICAL SYSTEM?

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

What is the FDA product code for MILLENNIUM MICROSURGICAL SYSTEM?

The FDA product code for MILLENNIUM MICROSURGICAL SYSTEM is GEX. This falls under the Gastroenterology category.

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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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