FDA 510(k)

VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS

K-Number: K012700 · 2001-11-07

ApplicantVanguard Medical Concepts, Inc.

Decision Date2001-11-07

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS 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 2001-11-07 under 510(k) number K012700. 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 ENDOSCOPIC INSTRUMENTS?

VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2001-11-07. The listed applicant is Vanguard Medical Concepts, Inc.. The 510(k) number is K012700.

When did VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS receive FDA 510(k) clearance?

VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS received FDA 510(k) clearance on 2001-11-07, under 510(k) number K012700.

Who is the listed applicant for VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS?

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 ENDOSCOPIC INSTRUMENTS?

The FDA product code for VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS 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.