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FDA 510(k)

ENDOSCOPE

K-Number: K925968 · 1994-04-28

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1994-04-28
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1994-04-28 under 510(k) number K925968. 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 ENDOSCOPE?

ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1994-04-28. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K925968.

When did ENDOSCOPE receive FDA 510(k) clearance?

ENDOSCOPE received FDA 510(k) clearance on 1994-04-28, under 510(k) number K925968.

Who is the listed applicant for ENDOSCOPE?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSCOPE?

The FDA product code for ENDOSCOPE is HET.

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Other records listing United States Surgical, A Division of Tyco Healthc 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.

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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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