FDA 510(k)

REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS

K-Number: K012624 · 2001-11-08

ApplicantMedical Instruments Technology, Inc.

Decision Date2001-11-08

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instruments Technology, Inc.. It received FDA 510(k) clearance on 2001-11-08 under 510(k) number K012624. 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 REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS?

REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS is a medical device that received FDA 510(k) clearance on 2001-11-08. The listed applicant is Medical Instruments Technology, Inc.. The 510(k) number is K012624.

When did REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS receive FDA 510(k) clearance?

REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS received FDA 510(k) clearance on 2001-11-08, under 510(k) number K012624.

Who is the listed applicant for REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS?

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

What is the FDA product code for REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS?

The FDA product code for REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS is HRX.

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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.