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FDA 510(k)

ARTHREX AR-8200 SHAVER SYSTEM

K-Number: K932699 · 1994-01-25

ApplicantArthrex, Inc.
Decision Date1994-01-25
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHREX AR-8200 SHAVER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1994-01-25 under 510(k) number K932699. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHREX AR-8200 SHAVER SYSTEM?

ARTHREX AR-8200 SHAVER SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-25. The listed applicant is Arthrex, Inc.. The 510(k) number is K932699.

When did ARTHREX AR-8200 SHAVER SYSTEM receive FDA 510(k) clearance?

ARTHREX AR-8200 SHAVER SYSTEM received FDA 510(k) clearance on 1994-01-25, under 510(k) number K932699.

Who is the listed applicant for ARTHREX AR-8200 SHAVER SYSTEM?

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

What is the FDA product code for ARTHREX AR-8200 SHAVER SYSTEM?

The FDA product code for ARTHREX AR-8200 SHAVER SYSTEM is HWE.

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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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