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FDA 510(k)

WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175

K-Number: K963227 · 1996-10-23

ApplicantProducts For Medicine
Decision Date1996-10-23
Product CodeGCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 is the device name listed in this FDA 510(k) record. The listed applicant is Products For Medicine. It received FDA 510(k) clearance on 1996-10-23 under 510(k) number K963227. The device is classified under product code GCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175?

WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 is a medical device that received FDA 510(k) clearance on 1996-10-23. The listed applicant is Products For Medicine. The 510(k) number is K963227.

When did WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 receive FDA 510(k) clearance?

WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 received FDA 510(k) clearance on 1996-10-23, under 510(k) number K963227.

Who is the listed applicant for WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175?

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

What is the FDA product code for WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175?

The FDA product code for WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 is GCT.

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 Products For Medicine 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.

K955510X6000D SILENT SUN LIGHT SOURCEK953089I-SPOUSEK951704NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATIONK951703TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORSK883658I-SPOSE EYE SHIELD

Related Devices (Code: GCT)

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.

K093125ALPHAXENON LIGHT 180 W AND 300 WGimmi GmbHK082925XENON-100 SCB LIGHT SOURCE, MODEL 20132620KARL STORZ Endoscopy-America, Inc.K070376CONMED LINVATEC 300W XENON LIGHT SOURCEConmed LinvatecK040949VIADUCT MINISCOPE AND ACCESSORIESAcueity, Inc.K022490KSEA MEDI PACKKARL STORZ Endoscopy-America, Inc.K031994LINVATEC 300W XENON LIGHT SOURCELinvatec Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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