FDA 510(k)

S698 Symbioz flow

K-Number: K153367 · 2016-06-17

Decision Date2016-06-17

Product CodeHIF

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

S698 Symbioz flow is the device name listed in this FDA 510(k) record. The listed applicant is Sopro - Acteon Group. It received FDA 510(k) clearance on 2016-06-17 under 510(k) number K153367. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S698 Symbioz flow?

S698 Symbioz flow is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Sopro - Acteon Group. The 510(k) number is K153367.

When did S698 Symbioz flow receive FDA 510(k) clearance?

S698 Symbioz flow received FDA 510(k) clearance on 2016-06-17, under 510(k) number K153367.

Who is the listed applicant for S698 Symbioz flow?

The FDA 510(k) record lists Sopro - Acteon Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S698 Symbioz flow?

The FDA product code for S698 Symbioz flow is HIF.

Related Devices (Code: HIF)

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.

K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KG K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation K242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group

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.