ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II

FDA Device Registration & Listing · CIUDAD JUAREZ Chihuahua, MX · Registration 9710649

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9710649
FEI Number
3003565435
Entity Name
ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II
City/State/Country
CIUDAD JUAREZ Chihuahua, MX
Establishment Address
CALLE DURANGO No. 2751, COLONIA LOTE BRAVO, CIUDAD JUAREZ Chihuahua --32575, MX
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ETHICON ENDO-SURGERY, INC. (Owner Number: 9010225)
Owner / Operator Contact Address
4545 CREEK RD., ML #39, Cincinnati, OH 45242, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ECHELON™ 45 Endopath® Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology) ENSEAL X1 Tissue Sealer ENDOPATH HARMONIC HARMONIC ACE Harmonic 500 ENSEAL ENDOPATH ETHICON LINX® Esophagus Sizing Tool ENDOPATH ENDOPATH ECHELON ECHELON ENDOPATH Gen11 Accessories Harmonic Focus Long Shears + Adaptive Tissue Technology LIGACLIP MCA Harmonic HD 1000i Shears, 20cm, 36cm ENDOPOUCH 12-L 12MM Endoscopic ROTATING MULTIPLE CLIP APLLIER LIGACLIP ValuTrus ADVANT PROXIMATE ENSEAL® X1 Straight Jaw Tissue Sealer ENSEAL ECHELON 3000 45mm Stapler; ECHELON 3000 60mm Stapler Echelon Contour Curved Cutter with reloads CONTOUR ETHICON 3D Reloads; ETHICON 4000 Staplers 60 mm ENDOPATH XCEL HARMONIC FOCUS Shears + Adaptive Tissue Technology ENSEAL 1X Tissue Sealer, Curved Jaw, Articulating Echelon Flex Powered Plus Endopath Electrosurgery Probe Plus II Echelon Circular Powered Stapler HARMONIC ACE+ HARMONIC ENDOPATH XCEL ENDOPATH HARMONIC ACE® Curved Shears LIGACLIP ECHELON FLEX POWERED Harmonic 1100 Generator G11 Endopath Electrosurgery Probe Plus II FLEXIPATH ENSEAL X1 Tissue Sealers, Curved and Straight, 25cm, 37cm, 45cm LIGAMAX Enseal X1 Large Jaw Tissue Sealer HARMONIC ACE ETHICONTM 3D 45mm Reload ETHICONTM 4000 45mm Stapler ECHELON 3D Reload ECHELON 4000 Stapler 60 mm HARMONIC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2017-01-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-12-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-01-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-01-17
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2014-10-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-11-07
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-01-21
QJN Laparoscopic Accessories, Esophageal Sizing Gastroenterology, Urology Class 2 876.5360 2023-02-28
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-01-21
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2013-04-09
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2008-01-17
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2008-01-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-09-20
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2016-09-20
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2016-09-20
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2015-07-13
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2008-01-21
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2020-03-03
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-01-21
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2019-01-24
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2025-02-28
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2008-01-21
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2021-02-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-02-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-04-11
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2013-04-11
GAG Stapler, Surgical General Hospital Class 2 878.4740 2022-04-19
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2020-08-11
GAG Stapler, Surgical General Hospital Class 2 878.4740 2010-07-29
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2010-07-29
GAG Stapler, Surgical General Hospital Class 2 878.4740 2025-05-20
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-05-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-01-17
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2013-12-06
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2018-05-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-24
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2014-04-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-05-10
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2017-06-02
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2013-11-11
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2008-01-17
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-01-21
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-11-27
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2016-04-19
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2008-01-17
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2014-12-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-05-14
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2020-05-14
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2020-05-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-18
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-01-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-11-29
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2017-11-29
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2011-04-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-02-15
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2017-02-15
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2017-02-15
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2013-12-18
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-12-19
GAG Stapler, Surgical General Hospital Class 2 878.4740 2025-12-19
GAG Stapler, Surgical General Hospital Class 2 878.4740 2024-10-29
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2024-10-29
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2008-01-21

Official Correspondent

Emily Nesbitt

US Agent Details

Roberta Franca Email: rfranca@its.jnj.com Phone: (513) 3378855

Related Public Records

Same Entity

ETHICON ENDO-SURGERY, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1527736 ETHICON ENDO-SURGERY, INC. Cincinnati, OH, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K131563 Opus Ksd, Inc. SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM 2014-04-09
K131705 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY 2013-07-01
K103263 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY 2010-11-22
K130717 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RELOAD 2013-04-18
K221006 Covidien GIA Stapler with Tri-Staple Technology 2022-04-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2021 N/A 2
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0005-2021 N/A 2
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710649. Last updated year: 2026. Please use registration number 9710649 when referencing this establishment in official correspondence.
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