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FDA 510(k)

AbClose - Port Site Closure Device

K-Number: K160117 · 2016-09-09

ApplicantMedeon Biodesign, Inc.
Decision Date2016-09-09
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AbClose - Port Site Closure Device is the device name listed in this FDA 510(k) record. The listed applicant is Medeon Biodesign, Inc.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K160117. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AbClose - Port Site Closure Device?

AbClose - Port Site Closure Device is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Medeon Biodesign, Inc.. The 510(k) number is K160117.

When did AbClose - Port Site Closure Device receive FDA 510(k) clearance?

AbClose - Port Site Closure Device received FDA 510(k) clearance on 2016-09-09, under 510(k) number K160117.

Who is the listed applicant for AbClose - Port Site Closure Device?

The FDA 510(k) record lists Medeon Biodesign, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AbClose - Port Site Closure Device?

The FDA product code for AbClose - Port Site Closure Device is OCW.

Related Clinical Trials

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.

NCT05492721Comparing Tissue Adhesives in Port Site ClosureCOMPLETEDNCT07649915GRIP: Gordian Robotic Integrated Port Closure StudyNOT_YET_RECRUITING

Other records listing Medeon Biodesign, Inc. 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.

K200902ClickCleanK193652AbClose - Port Site Closure DeviceK192891Laparoscope Lens Shield Device (LENS)K170103Laparoscope Lens Shield Device (LENS)K160172Laparoscope Lens Shield Device

Related Devices (Code: OCW)

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.

K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.K243750SimpleStitch Suturing SystemEnvision EndoscopyK231240MaxTack™ Motorized Fixation DeviceCovidienK213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis MedicalK231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.K211309endomina systemEndo Tools Therapeutics S.A.

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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