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FDA 510(k)

MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)

K-Number: K081698 · 2008-07-30

ApplicantImage Stream Medical, Inc.
Decision Date2008-07-30
Product CodeFTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) is the device name listed in this FDA 510(k) record. The listed applicant is Image Stream Medical, Inc.. It received FDA 510(k) clearance on 2008-07-30 under 510(k) number K081698. 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 MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)?

MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) is a medical device that received FDA 510(k) clearance on 2008-07-30. The listed applicant is Image Stream Medical, Inc.. The 510(k) number is K081698.

When did MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) receive FDA 510(k) clearance?

MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) received FDA 510(k) clearance on 2008-07-30, under 510(k) number K081698.

Who is the listed applicant for MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)?

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

What is the FDA product code for MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)?

The FDA product code for MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) is FTA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Image Stream 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.

K102791EASYSUITE SURGICAL LIGHT CONTROL (ESLC)

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.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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