Data / Medical devices / United States / Teleflex Medical Inc.
Teleflex Medical Inc.: FDA-registered device maker in Cincinnati, OH, United States, 4 510(k) clearances
Teleflex Medical Inc. is registered with the FDA (registration 3012481535) in Cincinnati, OH, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012481535
- Address
- 4300 Glendale Milford Road, Cincinnati, OH, United States, 45242
- Owner or operator
- Teleflex (9062981)
- Roles
- Specification developer
- First device listed
- January 6, 2023
- Registered through
- 2026
- Brand names listed
- Standard Precision Bougie Device, Standard Staple-Line Reinforcement, Standard Tapered Bougie, 38 Fr (STB38), Standard Trocar, Titan SGS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Staple Line Reinforcement | OXC | 2 | Specification developer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Specification developer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 6, 2023 | K231603 | Standard Staple-Line Reinforcement (SSLR23) | OXC | Substantially Equivalent | Standard Bariatrics, Inc. | accessdata.fda.gov |
| October 31, 2022 | K222085 | Standard Tapered Bougie, 38 Fr. | KNT | Substantially Equivalent | Standard Bariatrics, Inc. | accessdata.fda.gov |
| April 28, 2021 | K210278 | Titan SGS | GDW | Substantially Equivalent | Standard Bariatrics | accessdata.fda.gov |
| April 9, 2020 | K200517 | Standard Trocar | GCJ | Substantially Equivalent | Standard Bariatrics | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Absorbable, Staple Line Reinforcement
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Staple, Implantable
Updated October 6, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.