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FDA 510(k)

S1500 XENON LIGHT SOURCE

K-Number: K922837 · 1992-11-03

ApplicantEndomedix
Decision Date1992-11-03
Product CodeHBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

S1500 XENON LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Endomedix. It received FDA 510(k) clearance on 1992-11-03 under 510(k) number K922837. The device is classified under product code HBI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S1500 XENON LIGHT SOURCE?

S1500 XENON LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 1992-11-03. The listed applicant is Endomedix. The 510(k) number is K922837.

When did S1500 XENON LIGHT SOURCE receive FDA 510(k) clearance?

S1500 XENON LIGHT SOURCE received FDA 510(k) clearance on 1992-11-03, under 510(k) number K922837.

Who is the listed applicant for S1500 XENON LIGHT SOURCE?

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

What is the FDA product code for S1500 XENON LIGHT SOURCE?

The FDA product code for S1500 XENON LIGHT SOURCE is HBI.

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Other records listing Endomedix 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.

K934170ENDOMEDIX Y-ADAPTERK934623ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERAK930499GRASPING FORCEPS FLEXIBLE STONE DISLODGERK930349STONE RETRIEVAL BASKETK926004ENDOSCOPE AND ACCOSSORIESK922082LAPAROSCOPIC INTRODUCER

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Related Devices (Code: HBI)

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.

K223183Light-Guide CablesOlympus Winter & Ibe GmbHK163185OptiLux LED IlluminatorIsolux, LLCK111342LIGHT GUIDE CABLESchott North AmericaK0529791125 XSB XENON FIBER-OPTIC LIGHT SOURCEIsolux, LLCK021931ENDOSCOPIC FIBEROPTIC CABLEGulf Medical FiberopticsK991208ENDOSCOPIC FIBEROPTIC CABLEIsolux America

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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