Data / Medical devices / South Korea / SMC
SMC: FDA-registered device maker in Gimpo-si Gyeonggi, South Korea, 1 510(k) clearance
SMC is registered with the FDA (registration 3011221234) in Gimpo-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 1, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011221234
- Address
- 30, Daeposandan-ro,Yangchon-eup, Gimpo-si Gyeonggi, South Korea, 10048
- Owner or operator
- SMC (10048258)
- Roles
- Manufacturer
- First device listed
- December 22, 2014
- Registered through
- 2027
- Brand names listed
- SMC Acupuncture Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Acupuncture, Single Use | MQX | 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 |
|---|---|---|---|---|---|---|
| August 1, 2014 | K141473 | SMC ACUPUNCTURE NEEDLE | MQX | Substantially Equivalent | Smc Intl., Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 1, 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.