Data / Medical devices / South Korea / Standard Sci-Tech Inc.
Standard Sci-Tech Inc.: FDA-registered device maker in Seoul, South Korea, 4 510(k) clearances
Standard Sci-Tech Inc. is registered with the FDA (registration 3009906660) in Seoul, South Korea. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 17, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009906660
- Address
- 1F Sewoon Medical Bldg., 46 Wangsan-Ro, Dongdaemun-Gu, Seoul, South Korea, 02583
- Owner or operator
- STANDARD SCI-TECH INC. (10054336)
- Roles
- Exporter to the US
- First device listed
- March 8, 2017
- Registered through
- 2026
- Brand names listed
- Bonastent
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Esophageal | ESW | 2 | Exporter to the US | accessdata.fda.gov |
| Prosthesis, Tracheal, Expandable | JCT | 2 | Exporter to the US | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Exporter to the US | 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 17, 2014 | K140472 | BONASTENT TRACHEAL / BRONCHIAL | JCT | Substantially Equivalent | Endochoice, Inc. | accessdata.fda.gov |
| June 16, 2014 | K140760 | BONASTENT BILIARY | FGE | Unknown | Endochoice, Inc. | accessdata.fda.gov |
| March 24, 2010 | K093003 | BONASTENT BILIARY | FGE | Unknown | Endochoice, Inc. | accessdata.fda.gov |
| February 22, 2010 | K092144 | BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR | ESW | Substantially Equivalent | Endochoice, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Prosthesis, Esophageal
- All makers of Prosthesis, Tracheal, Expandable
Updated October 17, 2014. 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.