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FDA 510(k)

RIGID ENDOSCOPE

K-Number: K853514 · 1985-10-04

ApplicantAmerican Edwards Laboratories
Decision Date1985-10-04
Product CodeGCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RIGID ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853514. 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 RIGID ENDOSCOPE?

RIGID ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is American Edwards Laboratories. The 510(k) number is K853514.

When did RIGID ENDOSCOPE receive FDA 510(k) clearance?

RIGID ENDOSCOPE received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853514.

Who is the listed applicant for RIGID ENDOSCOPE?

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

What is the FDA product code for RIGID ENDOSCOPE?

The FDA product code for RIGID ENDOSCOPE is GCM.

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Other records listing American Edwards Laboratories 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.

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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

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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