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FDA 510(k)

STRYKER LED LIGHTSOURCE

K-Number: K082813 · 2008-12-19

ApplicantStryker Corp.
Decision Date2008-12-19
Product CodeFCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STRYKER LED LIGHTSOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2008-12-19 under 510(k) number K082813. The device is classified under product code FCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER LED LIGHTSOURCE?

STRYKER LED LIGHTSOURCE is a medical device that received FDA 510(k) clearance on 2008-12-19. The listed applicant is Stryker Corp.. The 510(k) number is K082813.

When did STRYKER LED LIGHTSOURCE receive FDA 510(k) clearance?

STRYKER LED LIGHTSOURCE received FDA 510(k) clearance on 2008-12-19, under 510(k) number K082813.

Who is the listed applicant for STRYKER LED LIGHTSOURCE?

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

What is the FDA product code for STRYKER LED LIGHTSOURCE?

The FDA product code for STRYKER LED LIGHTSOURCE is FCW.

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Other records listing Stryker Corp. as applicant

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Related Devices (Code: FCW)

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.

K123956POWER LED 175KARL STORZ Endoscopy-America, Inc.K123359OVS1 VIDEO SYSTEMOlive Medical Corp.K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2Richard Wolf Medical Instruments Corp.K093792LED LIGHT SOURCESunoptic Technologies, LLCK091968KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020CKARL STORZ Endoscopy-America, Inc.K081477LUXTEC MLX LIGHT SOURCEIntegra Luxtec, Inc.

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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