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FDA 510(k)

GYNECOLOGICAL LAPAROSCOPES

K-Number: K003805 · 2001-07-22

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

Device Summary

GYNECOLOGICAL LAPAROSCOPES 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 K003805. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNECOLOGICAL LAPAROSCOPES?

GYNECOLOGICAL LAPAROSCOPES 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 K003805.

When did GYNECOLOGICAL LAPAROSCOPES receive FDA 510(k) clearance?

GYNECOLOGICAL LAPAROSCOPES received FDA 510(k) clearance on 2001-07-22, under 510(k) number K003805.

Who is the listed applicant for GYNECOLOGICAL LAPAROSCOPES?

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 GYNECOLOGICAL LAPAROSCOPES?

The FDA product code for GYNECOLOGICAL LAPAROSCOPES is HET.

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.

K003802HYSTEROSCOPESK003831ARTHROSCOPESK003830ENT ENDOSCOPESK003803GENERAL SURGICAL LAPAROSCOPESK003807CYSTOSCOPESK003806URETEROSCOPES

View all 7 devices →

Related Devices (Code: HET)

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.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , 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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