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 NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)

K-Number: K011257 · 2001-07-13

ApplicantEthicon Endo-Surgery, Inc.
Decision Date2001-07-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) 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 2001-07-13 under 510(k) number K011257. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)?

ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) is a medical device that received FDA 510(k) clearance on 2001-07-13. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K011257.

When did ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) receive FDA 510(k) clearance?

ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) received FDA 510(k) clearance on 2001-07-13, under 510(k) number K011257.

Who is the listed applicant for ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)?

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 NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)?

The FDA product code for ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) is GCJ.

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: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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.

↑