Data / Medical devices / South Korea / Purgo Biologics Inc.
Purgo Biologics Inc.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 6 510(k) clearances
Purgo Biologics Inc. is registered with the FDA (registration 3014448321) in Seongnam-si Gyeonggi, South Korea. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 24, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014448321
- Address
- #812, 27, Dunchon-daero 457 beon-gil,Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13219
- Owner or operator
- PURGO BIOLOGICS Inc. (10053793)
- Roles
- Manufacturer
- First device listed
- October 3, 2018
- Registered through
- 2027
- Brand names listed
- Biotex, CYTOSHIELD, OpenTex, TBS PTFE Membrane, TBS PTFE Suture, THE Cover, THE Graft, THE Graft Collagen
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | 2 | Manufacturer | accessdata.fda.gov |
| Barrier, Synthetic, Intraoral | NPK | 2 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Animal Source | NPM | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 24, 2024 | K230305 | THE Graft Collagen | NPM | Substantially Equivalent | Purgo Biologics, Inc. | accessdata.fda.gov |
| October 6, 2023 | K230091 | THE Cover | NPL | Substantially Equivalent | Purgo Biologics, Inc. | accessdata.fda.gov |
| May 11, 2023 | K222549 | OpenTex | NPK | Substantially Equivalent | Purgo Biologics, Inc. | accessdata.fda.gov |
| February 14, 2020 | K191737 | The Graft Bone Substitute | NPM | Substantially Equivalent | Purgo Biologics, Inc. | accessdata.fda.gov |
| July 16, 2019 | K180992 | Biotex | NBY | Substantially Equivalent | Purgo Biologics, Inc. | accessdata.fda.gov |
| July 20, 2018 | K173188 | The Graft Natural Bone Substitute | NPM | Substantially Equivalent | Purgo Biologics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bone Grafting Material, Animal Source
- All makers of Barrier, Animal Source, Intraoral
- All makers of Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- All makers of Barrier, Synthetic, Intraoral
Updated July 24, 2024. 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.