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FDA 510(k)

SurgiQuest AIRSEAL iFS System

K-Number: K172516 · 2018-03-16

ApplicantConmed Corporation
Decision Date2018-03-16
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SurgiQuest AIRSEAL iFS System is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K172516. 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 SurgiQuest AIRSEAL iFS System?

SurgiQuest AIRSEAL iFS System is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Conmed Corporation. The 510(k) number is K172516.

When did SurgiQuest AIRSEAL iFS System receive FDA 510(k) clearance?

SurgiQuest AIRSEAL iFS System received FDA 510(k) clearance on 2018-03-16, under 510(k) number K172516.

Who is the listed applicant for SurgiQuest AIRSEAL iFS System?

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

What is the FDA product code for SurgiQuest AIRSEAL iFS System?

The FDA product code for SurgiQuest AIRSEAL iFS System is HIF.

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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. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems CorporationK242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group

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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