Teleflex Medical Inc.

FDA Device Registration & Listing · Cincinnati, OH, US · Registration 3012481535

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
3012481535
FEI Number
3012481535
Entity Name
Teleflex Medical Inc.
City/State/Country
Cincinnati, OH, US
Establishment Address
4300 Glendale Milford Road, Cincinnati, OH 45242, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Teleflex (Owner Number: 9062981)
Owner / Operator Contact Address
3015 Carrington Mill Blvd., Morrisville, NC 27560, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222085
PMA Number
N/A

All Registered Proprietary Names

Standard Staple-Line Reinforcement Titan SGS Standard Trocar Standard Tapered Bougie, 38 Fr (STB38) Standard Precision Bougie Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2023-11-29
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2023-01-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-01-06
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2023-01-06

Official Correspondent

Divya Raman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Teleflex
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013515223 T.K. India Pvt. Ltd. Chandigarh, IN
3004365956 Teleflex Medical de Mexico, S. de R.L. de C.V. NUEVO LAREDO Tamaulipas, MX
3010041511 Teleflex LLC (NADC) Olive Branch, MS, US
3007134520 TELEFLEX MEDICAL ATHLONE Westmeath, IE
8040412 Teleflex Medical Sdn. Bhd. KAMUNTING Perak, MY

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.

Similar Registrations

Registration Number Establishment Name Location
3014272734 GMED Healthcare BVBA ( a Johnson & Johnson Company) Courcelles Luxembourg, BE
3002294946 Johnson & Johnson MEDICAL GmbH NORDERSTEDT Schleswig-Holstein, DE
3027419979 GUNZE MEDICAL LIMITED Osaka, JP
3009380063 Medtronic Distribution Center Memphis, TN, US
3011137372 Teleflex Medical LLC Morrisville, NC, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012481535. Last updated year: 2026. Please use registration number 3012481535 when referencing this establishment in official correspondence.
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