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FDA 510(k)

HYSTEROSCOPES

K-Number: K003802 · 2001-07-22

ApplicantGlobal Endoscopy, Inc.
Decision Date2001-07-22
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HYSTEROSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Global Endoscopy, Inc.. It received FDA 510(k) clearance on 2001-07-22 under 510(k) number K003802. 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 HYSTEROSCOPES?

HYSTEROSCOPES is a medical device that received FDA 510(k) clearance on 2001-07-22. The listed applicant is Global Endoscopy, Inc.. The 510(k) number is K003802.

When did HYSTEROSCOPES receive FDA 510(k) clearance?

HYSTEROSCOPES received FDA 510(k) clearance on 2001-07-22, under 510(k) number K003802.

Who is the listed applicant for HYSTEROSCOPES?

The FDA 510(k) record lists Global Endoscopy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYSTEROSCOPES?

The FDA product code for HYSTEROSCOPES is HIH.

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.

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Other records listing Global Endoscopy, Inc. 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.

K003805GYNECOLOGICAL LAPAROSCOPESK003831ARTHROSCOPESK003830ENT ENDOSCOPESK003803GENERAL SURGICAL LAPAROSCOPESK003807CYSTOSCOPESK003806URETEROSCOPES

View all 7 devices →

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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