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FDA 510(k)

REPROCESSED STRYKER ARTHROSCOPIC SHAVERS

K-Number: K012635 · 2001-11-07

ApplicantAlliance Medical Corp.
Decision Date2001-11-07
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REPROCESSED STRYKER ARTHROSCOPIC SHAVERS is the device name listed in this FDA 510(k) record. The listed applicant is Alliance Medical Corp.. It received FDA 510(k) clearance on 2001-11-07 under 510(k) number K012635. 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 STRYKER ARTHROSCOPIC SHAVERS?

REPROCESSED STRYKER ARTHROSCOPIC SHAVERS is a medical device that received FDA 510(k) clearance on 2001-11-07. The listed applicant is Alliance Medical Corp.. The 510(k) number is K012635.

When did REPROCESSED STRYKER ARTHROSCOPIC SHAVERS receive FDA 510(k) clearance?

REPROCESSED STRYKER ARTHROSCOPIC SHAVERS received FDA 510(k) clearance on 2001-11-07, under 510(k) number K012635.

Who is the listed applicant for REPROCESSED STRYKER ARTHROSCOPIC SHAVERS?

The FDA 510(k) record lists Alliance Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED STRYKER ARTHROSCOPIC SHAVERS?

The FDA product code for REPROCESSED STRYKER ARTHROSCOPIC SHAVERS is HRX.

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Other records listing Alliance Medical Corp. as applicant

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.

K060648REPROCESSED PHACOEMULSIFICATION TIPSK061045REPROCESSED ELECTROPHYSIOLOGY CATHETERSK060049REPROCESSED COMPRESSION SLEEVESK060091ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVESK053316REPROCESSED COMPRESSION SLEEVESK052918REPROCESSED EXTERNAL FIXATION DEVICES

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Related Devices (Code: HRX)

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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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