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FDA 510(k)

OASYS SURGICAL LIGHT CONTROLLER

K-Number: K112133 · 2012-03-01

ApplicantOasys Healthcare
Decision Date2012-03-01
Product CodeFTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OASYS SURGICAL LIGHT CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is Oasys Healthcare. It received FDA 510(k) clearance on 2012-03-01 under 510(k) number K112133. 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 OASYS SURGICAL LIGHT CONTROLLER?

OASYS SURGICAL LIGHT CONTROLLER is a medical device that received FDA 510(k) clearance on 2012-03-01. The listed applicant is Oasys Healthcare. The 510(k) number is K112133.

When did OASYS SURGICAL LIGHT CONTROLLER receive FDA 510(k) clearance?

OASYS SURGICAL LIGHT CONTROLLER received FDA 510(k) clearance on 2012-03-01, under 510(k) number K112133.

Who is the listed applicant for OASYS SURGICAL LIGHT CONTROLLER?

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

What is the FDA product code for OASYS SURGICAL LIGHT CONTROLLER?

The FDA product code for OASYS SURGICAL LIGHT CONTROLLER is FTA.

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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.

K102791EASYSUITE SURGICAL LIGHT CONTROL (ESLC)Image Stream Medical, Inc.K081698MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)Image Stream Medical, Inc.K053321LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERXodus 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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