Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1527736

FEI Number

1527736

Entity Name

ETHICON ENDO-SURGERY, INC.

City/State/Country

Cincinnati, OH, US

Establishment Address

4545 CREEK RD., Cincinnati, OH 45242, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

Expiration Date (Year)

2026

510(k) Number

K132522

PMA Number

N/A

All Registered Proprietary Names

HARMONIC Harmonic HD 1000i Shears, 20cm, 36cm Echelon Circular Powered Stapler XCEL ENDOPATH ENDOPATH HARMONIC Gray Handpiece HARMONIC Blue Handpiece LIGAMAX ETHICONTM 3D 45mm Reload ETHICONTM 4000 45mm Stapler ENDOPATH XCEL Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier Endopath Electrosurgery Probe Plus II ValuTrus ADVANT PROXIMATE ENSEAL LIGACLIP Harmonic Scalpel Sterile Tray Echelon Flex Powered Plus ECHELON ENDOPATH Staple Line Reinforcement Mesh, surgical, absorbable, staple line reinforcement HARMONIC PROXIMATE ECHELON 3D Reload ECHELON 4000 Stapler 60 mm MEGADYNE Energy Signal Cable CONTOUR ENDOPATH Gen11 Accessories Ligaclip Endoscopic Clip Applier ETHICON 3D Reloads; ETHICON 4000 Staplers 60 mm ECHELON Ethicon Circular Stapler, XL Sealed and Ethicon Circular Stapler DUALTO Energy System ENDOPATH LIGACLIP MCA Harmonic Focus Long Shears + Adaptive Tissue Technology Ethicon Circular Stapler, XL Sealed and Ethicon Circular Stapler ECHELON 60 Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface Technology) HARMONIC ACE Harmonic 500 HARMONIC Enseal X1 Large Jaw Tissue Sealer ENSEAL 1X Tissue Sealer, Curved Jaw, Articulating ENSEAL ENDOPATH ECHELON Ethicon Endo-Surgery Linear Cutter ENDOPATH LIGACLIP ENDOPATH HARMONIC PROXIMATE ENDOSUTURE SYSTEM HARMONIC ECHELON PROXIMATE Echelon Contour Curved Cutter with reloads ENSEAL® X1 Curved Jaw Tissue Sealer ECHELON 45 Endopath® Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology) ETHICON Linx Esophagus Sizing Tool ENDOPATH ENSEAL X1 Tissue Sealers, Curved and Straight, 25cm, 37cm, 45cm Endopath Electrosurgery Probe Plus II ENSEAL® X1 Straight Jaw Tissue Sealer Echelon Linear Cutters HARMONIC ACE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2008-01-18
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-03-03
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2017-06-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-11-27
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2008-01-17
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2021-05-25
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2011-04-08
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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-17
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	2018-05-18
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-01-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-11-07
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2008-01-17
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2000-11-09
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2014-04-24
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2026-01-14
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2020-03-03
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2008-01-21
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-01-21
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
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2025-03-18
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
FDP	Apparatus, Pneumoperitoneum, Automatic	Gastroenterology, Urology	Class 2	876.1500	2006-02-16
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
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2001-06-11
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
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-01-17
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2026-05-20
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2025-01-23
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2025-01-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-01-23
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2006-02-16
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2008-01-21
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2015-07-13
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-07-30
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-08
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2014-10-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-01-17
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
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
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
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-01-21
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-06-02
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2010-04-15
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2010-04-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-01-18
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2008-01-21
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2001-06-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-21
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2008-01-17
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
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2000-11-09
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-08-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-01-25
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2021-01-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2017-01-06
QJN	Laparoscopic Accessories, Esophageal Sizing	Gastroenterology, Urology	Class 2	876.5360	2020-08-06
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-05-10
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
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-05-25
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-05-25
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2013-12-18

Official Correspondent

Emily Nesbitt

US Agent Details

No US Agent registered (Local establishment).

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
9710649	ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II	CIUDAD JUAREZ Chihuahua, MX

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-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1527736. Last updated year: 2026. Please use registration number 1527736 when referencing this establishment in official correspondence.