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FDA 510(k)

VANGUARD REPROCESSED ARTHROSCOPIC BLADES

K-Number: K012346 · 2001-10-16

ApplicantVanguard Medical Concepts, Inc.
Decision Date2001-10-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VANGUARD REPROCESSED ARTHROSCOPIC BLADES 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 2001-10-16 under 510(k) number K012346. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VANGUARD REPROCESSED ARTHROSCOPIC BLADES?

VANGUARD REPROCESSED ARTHROSCOPIC BLADES is a medical device that received FDA 510(k) clearance on 2001-10-16. The listed applicant is Vanguard Medical Concepts, Inc.. The 510(k) number is K012346.

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

VANGUARD REPROCESSED ARTHROSCOPIC BLADES received FDA 510(k) clearance on 2001-10-16, under 510(k) number K012346.

Who is the listed applicant for VANGUARD REPROCESSED ARTHROSCOPIC BLADES?

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 BLADES?

The FDA product code for VANGUARD REPROCESSED ARTHROSCOPIC BLADES is HRX.

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Other records listing Vanguard Medical Concepts, Inc. as applicant

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Related Devices (Code: HRX)

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.

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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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