Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015185328

FEI Number

3015185328

Entity Name

Nypro Healthcare Baja Inc. (Torres)

City/State/Country

Ciudad Juarez Chihuahua, MX

Establishment Address

Avenida de Las Torres #7125, Colonia Salvarcar 118, Ciudad Juarez Chihuahua 32580, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jabil Inc. (Owner Number: 9074019)

Owner / Operator Contact Address

10800 Roosevelt Blvd., Saint Petersburg, FL 33716, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ethicon Circular Stapler, XL Sealed and Ethicon Circular Stapler ECHELON LINEAR 60 mm Cutter (GLC60) ECHELON LINEAR Cutters 80mm Green ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G) ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B) ECHELON LINEAR 100 mm Cutter (GLC100) ECHELON LINEAR 80mm Cutter (GLC80) ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B) Ethicon Circular Stapler Ethicon Circular Stapler, XL Sealed ECHELON FLEXTM Powered Plus Articulating Endoscopic Linear cutters Echelon Contour Curved Cutter with reloads

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	2019-02-25
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2018-08-26
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-02-25
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2022-04-20
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2026-05-26
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-06-19
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-06-19
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-02-26
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-10-22
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-10-22
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2019-02-25
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2019-02-18
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25

Official Correspondent

No official correspondent registered.

US Agent Details

Lex Pearce Business: JABIL - NYPRO HEALTHCARE DIVISION Email: lex_pearce@jabil.com Phone: (505) 2030277

Related Public Records

Same Entity

Jabil 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
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US
3011246727	Jabil Circuit Sdn. Bhd.	Bayan Lepas Pulau Pinang, MY
3003512059	NYPRO DR, LLC (Bldg 11)	Haina San Cristobal, DO
3004730544	NYPRO DR, LLC (Building 52)	Haina San Cristobal, DO
1424235	Nypro Inc. (Chicago)	GURNEE, IL, 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 3015185328. Last updated year: 2026. Please use registration number 3015185328 when referencing this establishment in official correspondence.