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FDA 510(k)

LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER

K-Number: K053321 · 2006-01-19

ApplicantXodus Medical, Inc.
Decision Date2006-01-19
Product CodeFTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Xodus Medical, Inc.. It received FDA 510(k) clearance on 2006-01-19 under 510(k) number K053321. The device is classified under product code FTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER?

LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER is a medical device that received FDA 510(k) clearance on 2006-01-19. The listed applicant is Xodus Medical, Inc.. The 510(k) number is K053321.

When did LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER receive FDA 510(k) clearance?

LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER received FDA 510(k) clearance on 2006-01-19, under 510(k) number K053321.

Who is the listed applicant for LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER?

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

What is the FDA product code for LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER?

The FDA product code for LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER is FTA.

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Other records listing Xodus Medical, Inc. 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.

K260903Hot Pink Pad Warming SystemK182080Scope Antifogging SystemK081647ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPSK063587XODUS MEDICAL ANTI-FOG SOLUTIONK053433CAUTERY TIP CLEANER, MODEL 30500

Related Devices (Code: FTA)

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.

K112133OASYS SURGICAL LIGHT CONTROLLEROasys HealthcareK102791EASYSUITE SURGICAL LIGHT CONTROL (ESLC)Image Stream Medical, Inc.K081698MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)Image Stream Medical, Inc.K051505SCB/STERIS OR-LIGHT INTERFACE BOXKARL STORZ Endoscopy-America, Inc.K023704KSEA SCB ACC CONTROLKARL STORZ Endoscopy-America, Inc.K020640KSEA SCB MEDIA CONTROLKARL STORZ Endoscopy-America, 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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