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FDA 510(k)

GALILEO ENDOSCOPES

K-Number: K962116 · 1996-11-27

ApplicantGalileo Electro-Optics Corp.
Decision Date1996-11-27
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GALILEO ENDOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Galileo Electro-Optics Corp.. It received FDA 510(k) clearance on 1996-11-27 under 510(k) number K962116. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALILEO ENDOSCOPES?

GALILEO ENDOSCOPES is a medical device that received FDA 510(k) clearance on 1996-11-27. The listed applicant is Galileo Electro-Optics Corp.. The 510(k) number is K962116.

When did GALILEO ENDOSCOPES receive FDA 510(k) clearance?

GALILEO ENDOSCOPES received FDA 510(k) clearance on 1996-11-27, under 510(k) number K962116.

Who is the listed applicant for GALILEO ENDOSCOPES?

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

What is the FDA product code for GALILEO ENDOSCOPES?

The FDA product code for GALILEO ENDOSCOPES is EOB.

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Other records listing Galileo Electro-Optics 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.

K981928GALILEO DISPOSABLE ENDOSCOPESK962256GALILEO HYSTEROSCOPES AND LAPAROSCOPESK934649GALILEO ENDOSCOPESK934707GALILEO ARTHROSCOPESK936280GALILEO ARTHROSCOPESK936279GALILEO ENDOSCOPES

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Related Devices (Code: EOB)

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.

K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)Karl Storz SE & CO. KGK261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLC

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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