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FDA 510(k)

ACE STAPLER AND CARTRIDGE

K-Number: K120147 · 2012-02-17

ApplicantBarosense, Inc.
Decision Date2012-02-17
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACE STAPLER AND CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Barosense, Inc.. It received FDA 510(k) clearance on 2012-02-17 under 510(k) number K120147. 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 ACE STAPLER AND CARTRIDGE?

ACE STAPLER AND CARTRIDGE is a medical device that received FDA 510(k) clearance on 2012-02-17. The listed applicant is Barosense, Inc.. The 510(k) number is K120147.

When did ACE STAPLER AND CARTRIDGE receive FDA 510(k) clearance?

ACE STAPLER AND CARTRIDGE received FDA 510(k) clearance on 2012-02-17, under 510(k) number K120147.

Who is the listed applicant for ACE STAPLER AND CARTRIDGE?

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

What is the FDA product code for ACE STAPLER AND CARTRIDGE?

The FDA product code for ACE STAPLER AND CARTRIDGE 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.

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Other records listing Barosense, 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.

K120126BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIEK110829ACE STAPLER AND CARTRIDGEK082044ACE STAPLER, MODEL F0031K082589BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034

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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