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FDA 510(k)

GALILEO HYSTEROSCOPES AND LAPAROSCOPES

K-Number: K962256 · 1996-12-06

ApplicantGalileo Electro-Optics Corp.
Decision Date1996-12-06
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GALILEO HYSTEROSCOPES AND LAPAROSCOPES 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 1996-12-06 under 510(k) number K962256. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALILEO HYSTEROSCOPES AND LAPAROSCOPES?

GALILEO HYSTEROSCOPES AND LAPAROSCOPES is a medical device that received FDA 510(k) clearance on 1996-12-06. The listed applicant is Galileo Electro-Optics Corp.. The 510(k) number is K962256.

When did GALILEO HYSTEROSCOPES AND LAPAROSCOPES receive FDA 510(k) clearance?

GALILEO HYSTEROSCOPES AND LAPAROSCOPES received FDA 510(k) clearance on 1996-12-06, under 510(k) number K962256.

Who is the listed applicant for GALILEO HYSTEROSCOPES AND LAPAROSCOPES?

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 HYSTEROSCOPES AND LAPAROSCOPES?

The FDA product code for GALILEO HYSTEROSCOPES AND LAPAROSCOPES is HIH.

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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 ENDOSCOPESK962116GALILEO ENDOSCOPESK934649GALILEO ENDOSCOPESK934707GALILEO ARTHROSCOPESK936280GALILEO ARTHROSCOPESK936279GALILEO ENDOSCOPES

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Related Devices (Code: HIH)

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.

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)Karl Storz SE & CO. KGK261102UNIDRIVE Select SystemKarl Storz SE & CO. KGK254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.

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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