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FDA 510(k)

VIDEO ENDOSCOPE SYSTEM

K-Number: K922418 · 1993-07-29

ApplicantBaxter Healthcare Corp
Decision Date1993-07-29
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VIDEO ENDOSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1993-07-29 under 510(k) number K922418. 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 VIDEO ENDOSCOPE SYSTEM?

VIDEO ENDOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 1993-07-29. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K922418.

When did VIDEO ENDOSCOPE SYSTEM receive FDA 510(k) clearance?

VIDEO ENDOSCOPE SYSTEM received FDA 510(k) clearance on 1993-07-29, under 510(k) number K922418.

Who is the listed applicant for VIDEO ENDOSCOPE SYSTEM?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIDEO ENDOSCOPE SYSTEM?

The FDA product code for VIDEO ENDOSCOPE SYSTEM is HET.

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Other records listing Baxter Healthcare Corp as applicant

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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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