FDA 510(k)

VANGUARD REPROCESSED ARTHROSCOPIC WANDS

K-Number: K012695 · 2001-10-30

ApplicantVanguard Medical Concepts, Inc.

Decision Date2001-10-30

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VANGUARD REPROCESSED ARTHROSCOPIC WANDS is the device name listed in this FDA 510(k) record. The listed applicant is Vanguard Medical Concepts, Inc.. It received FDA 510(k) clearance on 2001-10-30 under 510(k) number K012695. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VANGUARD REPROCESSED ARTHROSCOPIC WANDS?

VANGUARD REPROCESSED ARTHROSCOPIC WANDS is a medical device that received FDA 510(k) clearance on 2001-10-30. The listed applicant is Vanguard Medical Concepts, Inc.. The 510(k) number is K012695.

When did VANGUARD REPROCESSED ARTHROSCOPIC WANDS receive FDA 510(k) clearance?

VANGUARD REPROCESSED ARTHROSCOPIC WANDS received FDA 510(k) clearance on 2001-10-30, under 510(k) number K012695.

Who is the listed applicant for VANGUARD REPROCESSED ARTHROSCOPIC WANDS?

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

What is the FDA product code for VANGUARD REPROCESSED ARTHROSCOPIC WANDS?

The FDA product code for VANGUARD REPROCESSED ARTHROSCOPIC WANDS is GEI.

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Official Source

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