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FDA 510(k)

SurroundScope System

K-Number: K210104 · 2021-07-08

Applicant270surgical , Ltd.
Decision Date2021-07-08
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SurroundScope System is the device name listed in this FDA 510(k) record. The listed applicant is 270surgical , Ltd.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K210104. 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 SurroundScope System?

SurroundScope System is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is 270surgical , Ltd.. The 510(k) number is K210104.

When did SurroundScope System receive FDA 510(k) clearance?

SurroundScope System received FDA 510(k) clearance on 2021-07-08, under 510(k) number K210104.

Who is the listed applicant for SurroundScope System?

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 SurroundScope System?

The FDA product code for SurroundScope System 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.

K190190WV1 Endoscope

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.K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))Schoelly Fiberoptic GmbH

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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