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FDA 510(k)

GALILEO ARTHROSCOPES

K-Number: K934707 · 1994-10-07

ApplicantGalileo Electro-Optics Corp.
Decision Date1994-10-07
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GALILEO ARTHROSCOPES 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 1994-10-07 under 510(k) number K934707. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALILEO ARTHROSCOPES?

GALILEO ARTHROSCOPES is a medical device that received FDA 510(k) clearance on 1994-10-07. The listed applicant is Galileo Electro-Optics Corp.. The 510(k) number is K934707.

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

GALILEO ARTHROSCOPES received FDA 510(k) clearance on 1994-10-07, under 510(k) number K934707.

Who is the listed applicant for GALILEO ARTHROSCOPES?

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 ARTHROSCOPES?

The FDA product code for GALILEO ARTHROSCOPES is HRX.

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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 LAPAROSCOPESK962116GALILEO ENDOSCOPESK934649GALILEO ENDOSCOPESK936280GALILEO ARTHROSCOPESK936279GALILEO ENDOSCOPES

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Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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