Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ACE STAPLER AND CARTRIDGE

K-Number: K110829 · 2011-06-03

ApplicantBarosense, Inc.
Decision Date2011-06-03
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 2011-06-03 under 510(k) number K110829. 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 2011-06-03. The listed applicant is Barosense, Inc.. The 510(k) number is K110829.

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

ACE STAPLER AND CARTRIDGE received FDA 510(k) clearance on 2011-06-03, under 510(k) number K110829.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 BOUGIEK120147ACE 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑