Data / Medical devices / South Korea / Y.jacobs Medical Inc.
Y.jacobs Medical Inc.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 2 510(k) clearances
Y.jacobs Medical Inc. is registered with the FDA (registration 3011555199) in Seongnam-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 23, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011555199
- Address
- 5F 503, 504, 505 Joongang innotech 148 Sagimakgol-ro, Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 462-807
- Owner or operator
- Y.Jacobs Medical Inc. (10048079)
- Roles
- Manufacturer
- First device listed
- December 3, 2014
- Registered through
- 2027
- Brand names listed
- Y. JACOBS YOUNG'S THREAD, Youngs Pointer 100, Youngs Pointer 50, Youngs Starter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Guide, Needle, Surgical | GDF | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Catheter | GCB | 1 | Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 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 |
|---|---|---|---|---|---|---|
| November 23, 2016 | K160705 | Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, | NEW | Substantially Equivalent | Y. Jacobs Medical, Inc. | accessdata.fda.gov |
| September 11, 2015 | K143413 | J+PRAS YOUNG'S Thread | NEW | Substantially Equivalent | Y. Jacobs Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Surgical, Absorbable, Polydioxanone
- All makers of Guide, Needle, Surgical
- All makers of Needle, Catheter
Updated November 23, 2016. 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.