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FDA 510(k)

WV1 Endoscope

K-Number: K190190 · 2019-11-01

Applicant270surgical , Ltd.
Decision Date2019-11-01
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WV1 Endoscope is the device name listed in this FDA 510(k) record. The listed applicant is 270surgical , Ltd.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K190190. 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 WV1 Endoscope?

WV1 Endoscope is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is 270surgical , Ltd.. The 510(k) number is K190190.

When did WV1 Endoscope receive FDA 510(k) clearance?

WV1 Endoscope received FDA 510(k) clearance on 2019-11-01, under 510(k) number K190190.

Who is the listed applicant for WV1 Endoscope?

The FDA 510(k) record lists 270surgical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WV1 Endoscope?

The FDA product code for WV1 Endoscope is HET.

Other records listing 270surgical , Ltd. 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.

K210104SurroundScope System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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