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)

AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES

K-Number: K090470 · 2009-05-14

ApplicantCovidien
Decision Date2009-05-14
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2009-05-14 under 510(k) number K090470. 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 AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES?

AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES is a medical device that received FDA 510(k) clearance on 2009-05-14. The listed applicant is Covidien. The 510(k) number is K090470.

When did AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES receive FDA 510(k) clearance?

AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES received FDA 510(k) clearance on 2009-05-14, under 510(k) number K090470.

Who is the listed applicant for AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES?

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

What is the FDA product code for AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES?

The FDA product code for AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES 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 Covidien 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.

K241486Sofsilk™ Coated Braided Silk SutureK240077Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)K231934GIA™ Stapler with Tri-Staple™ TechnologyK231240MaxTack™ Motorized Fixation DeviceK223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)K232126EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil

View all 93 devices →

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.

↑