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FDA 510(k)

FIBER OPTIC ENDOSCOPE

K-Number: K921918 · 1993-08-17

ApplicantElectro Fiberoptics Corp.
Decision Date1993-08-17
Product CodeGCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FIBER OPTIC ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Electro Fiberoptics Corp.. It received FDA 510(k) clearance on 1993-08-17 under 510(k) number K921918. The device is classified under product code GCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBER OPTIC ENDOSCOPE?

FIBER OPTIC ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1993-08-17. The listed applicant is Electro Fiberoptics Corp.. The 510(k) number is K921918.

When did FIBER OPTIC ENDOSCOPE receive FDA 510(k) clearance?

FIBER OPTIC ENDOSCOPE received FDA 510(k) clearance on 1993-08-17, under 510(k) number K921918.

Who is the listed applicant for FIBER OPTIC ENDOSCOPE?

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

What is the FDA product code for FIBER OPTIC ENDOSCOPE?

The FDA product code for FIBER OPTIC ENDOSCOPE is GCM.

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 Electro Fiberoptics Corp. 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.

K943628ARTHROSCOPEK933145FIBEROPTIC LIGHTSOURCES AND CARRIERS

Related Devices (Code: GCM)

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.

K203226TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MMRichard Wolf Medical Instruments CorporationK083840MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPEMsi Medserv International Deutschland GmbHK001217INSIDE VIEWMonadnock Optics, Inc.K993103ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREESRichard Wolf Medical Instruments Corp.K993445OMNISONIC ENDOSCOPIC DEFLECTOROmnisonics Medical TechnologiesK962393KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATIONKARL STORZ Endoscopy-America, Inc.

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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