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FDA 510(k)

XENON-100 SCB LIGHT SOURCE, MODEL 20132620

K-Number: K082925 · 2008-12-18

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2008-12-18
Product CodeGCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

XENON-100 SCB LIGHT SOURCE, MODEL 20132620 is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2008-12-18 under 510(k) number K082925. 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 XENON-100 SCB LIGHT SOURCE, MODEL 20132620?

XENON-100 SCB LIGHT SOURCE, MODEL 20132620 is a medical device that received FDA 510(k) clearance on 2008-12-18. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K082925.

When did XENON-100 SCB LIGHT SOURCE, MODEL 20132620 receive FDA 510(k) clearance?

XENON-100 SCB LIGHT SOURCE, MODEL 20132620 received FDA 510(k) clearance on 2008-12-18, under 510(k) number K082925.

Who is the listed applicant for XENON-100 SCB LIGHT SOURCE, MODEL 20132620?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XENON-100 SCB LIGHT SOURCE, MODEL 20132620?

The FDA product code for XENON-100 SCB LIGHT SOURCE, MODEL 20132620 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.

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Other records listing KARL STORZ Endoscopy-America, 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.

K252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII SystemK223923HOPKINS Telescopes

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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 GmbHK070376CONMED LINVATEC 300W XENON LIGHT SOURCEConmed LinvatecK040949VIADUCT MINISCOPE AND ACCESSORIESAcueity, Inc.K022490KSEA MEDI PACKKARL STORZ Endoscopy-America, Inc.K031994LINVATEC 300W XENON LIGHT SOURCELinvatec Corp.K023468ENDOSCOPIC LIGHT SOURCE XL180/L3World of Medicine Lemke GmbH

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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