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)

ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER

K-Number: K980815 · 1998-05-01

ApplicantEthicon Endo-Surgery, Inc.
Decision Date1998-05-01
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, Inc.. It received FDA 510(k) clearance on 1998-05-01 under 510(k) number K980815. 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 ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER?

ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K980815.

When did ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER receive FDA 510(k) clearance?

ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER received FDA 510(k) clearance on 1998-05-01, under 510(k) number K980815.

Who is the listed applicant for ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER?

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

What is the FDA product code for ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER?

The FDA product code for ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER 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 Ethicon Endo-Surgery, 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.

K111195VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADSK110385ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTERK101520ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RHK102632ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLERK093896ETHICON ENDO SURGERY SLOTTED ANOSCOPEK091259ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS

View all 111 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.

↑