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FDA 510(k)

ENDOSCOPIC LIGHT SOURCE 250 ENDO

K-Number: K903790 · 1990-12-07

ApplicantOrlux Engineering and Instrumentation
Decision Date1990-12-07
Product CodeFCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC LIGHT SOURCE 250 ENDO is the device name listed in this FDA 510(k) record. The listed applicant is Orlux Engineering and Instrumentation. It received FDA 510(k) clearance on 1990-12-07 under 510(k) number K903790. The device is classified under product code FCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC LIGHT SOURCE 250 ENDO?

ENDOSCOPIC LIGHT SOURCE 250 ENDO is a medical device that received FDA 510(k) clearance on 1990-12-07. The listed applicant is Orlux Engineering and Instrumentation. The 510(k) number is K903790.

When did ENDOSCOPIC LIGHT SOURCE 250 ENDO receive FDA 510(k) clearance?

ENDOSCOPIC LIGHT SOURCE 250 ENDO received FDA 510(k) clearance on 1990-12-07, under 510(k) number K903790.

Who is the listed applicant for ENDOSCOPIC LIGHT SOURCE 250 ENDO?

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

What is the FDA product code for ENDOSCOPIC LIGHT SOURCE 250 ENDO?

The FDA product code for ENDOSCOPIC LIGHT SOURCE 250 ENDO is FCW.

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 Orlux Engineering and Instrumentation 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.

K903800FIBER OPTIC LIGHT CABLE

Related Devices (Code: FCW)

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.

K123956POWER LED 175KARL STORZ Endoscopy-America, Inc.K123359OVS1 VIDEO SYSTEMOlive Medical Corp.K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2Richard Wolf Medical Instruments Corp.K093792LED LIGHT SOURCESunoptic Technologies, LLCK091968KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020CKARL STORZ Endoscopy-America, Inc.K082813STRYKER LED LIGHTSOURCEStryker 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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