Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005075853

FEI Number

3005075853

Entity Name

ETHICON ENDO-SURGERY, LLC

City/State/Country

GUAYNABO, PR, US

Establishment Address

475 CALLE C, GUAYNABO, PR 00969, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ETHICON ENDO-SURGERY, LLC (Owner Number: 9071406)

Owner / Operator Contact Address

4545 Creek Rd, Cincinnati, OH 45242, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200841

PMA Number

N/A

All Registered Proprietary Names

Ethicon Endo-Surgery; Linear Cutter PROXIMATE HARMONIC ACE Harmonic 500 ENDOPATH ECHELON HARMONIC FOCUS ECHELON LIGACLIP - Endoscopic Clip Applier CONTOUR ENSEAL® X1 Curved Jaw Tissue Sealer ENDOPATH LAPRA-TY LIGACLIP HARMONIC EnSeal DUALTO Energy System HARMONIC ACE ENDOPATH XCEL ENDOPATH Harmonic HD1000i shears, 20cm, 36cm CONTOUR TRANSTAR 12-L 12MM Endoscopic ROTATING MULTIPLE CLIP APLLIER HARMONIC PROXIMATE ENDOPATH Circular Sizer ETHICON 3D Reloads; ETHICON 4000 Staplers 60 mm ECHELON ENDOPATH Staple Line Reinforcement ECHELON ENDOPATH ENDOPOUCH Enseal X1 Large Jaw Tissue Sealer ECHELON ETS-FLEX45 Articulating Endoscopic Linear Cutters Echelon Contour Curved Cutter with reloads. Ethicon Circular Stapler, XL Sealed and Ethicon Circular Stapler ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter LIGACLIP ENDOPATH PNEUMONEEDLE Ethicon Generator 11 FLEXIPATH ECHELON FLEX POWERED HARMONIC Scallop Blade and Generator G11 ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating Endopath Electrosurgery Probe Plus II ENSEAL X1 Tissue Sealers, Curved and Straight, 25cm, 37cm, 45cm Linear Cutter Ethicon Endo-Surgery HARMONIC ACE® Curved Shears HARMONIC Gray Handpiece HARMONIC Blue Handpiece Echelon Flex Powered Plus LIGACLIP MCA ENDOPATH HARMONIC ACE HARMONIC MEGADYNE Energy Signal Cable Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier ENSEAL PROXIMATE HARMONIC Endopath Electrosurgery Probe Plus II ENDOPATH BIPOLAR ACTIVE/RETURN CORD ADVANT PROXIMATE ValuTrus HARMONIC ENSEAL ENDOPATH ILS Echelon Linear Cutter ENDOPATH ULTRA VERESS INSUFFLATION NEEDLE LIGACLIP PROXIMATE ENSEAL® X1 Straight Jaw Tissue Sealer ECHELON 3000 45mm Stapler; ECHELON 3000 60mm Stapler ECHELON 45 Endopath® Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology) HARMONIC Generator G11 Harmonic 1100

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	2017-10-18
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2014-10-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-27
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-07-25
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2008-07-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-06-26
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2014-06-26
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-07-23
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2005-10-18
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2010-07-29
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2010-07-29
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-04-24
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2021-01-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-01-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-27
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2005-10-18
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2007-11-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-12-14
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2010-12-14
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2025-01-23
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2025-01-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-01-23
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2013-12-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-27
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2007-11-27
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-03-03
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2007-11-27
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-01-24
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2005-10-18
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
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2020-03-03
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2013-04-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-27
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
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2014-10-16
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2014-10-16
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2015-05-26
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-08-11
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-07-30
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2016-03-30
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2022-11-22
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2007-11-27
FDP	Apparatus, Pneumoperitoneum, Automatic	Gastroenterology, Urology	Class 2	876.1500	2005-11-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-20
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2016-09-20
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2016-09-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-27
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	2014-09-22
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2014-09-22
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2014-09-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-05-24
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	2016-05-10
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
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2009-09-24
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2009-09-24
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2016-04-20
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2021-05-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2014-04-24
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2005-10-18
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-12-02
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2013-11-07
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2007-11-27
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2025-03-18
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2015-12-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-11-07
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2007-11-27
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2007-11-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-05-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2005-11-30
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2007-11-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-27
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
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2007-11-27
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-05-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-05-25
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2005-12-09
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2007-11-27
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2007-11-27
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
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2022-04-19
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2017-01-06
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2007-11-27
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	2020-05-14

Official Correspondent

Emily Nesbitt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ETHICON ENDO-SURGERY, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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 3005075853. Last updated year: 2026. Please use registration number 3005075853 when referencing this establishment in official correspondence.