Data / Medical devices / South Korea / Smeng Co.,ltd.
Smeng Co.,ltd.: FDA-registered device maker in Busan, South Korea, 5 510(k) clearances
Smeng Co.,ltd. is registered with the FDA (registration 3008912461) in Busan, South Korea. It lists 14 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 7, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008912461
- Address
- 46, Nakdong-daero 1302beon-gil, Sasang-gu, Busan, South Korea, 46910
- Owner or operator
- SMENG co.,ltd. (10044758)
- Roles
- Manufacturer
- First device listed
- May 14, 2014
- Registered through
- 2026
- Brand names listed
- Ez-Tcon Mono, Ez-Tcon Needle, Ez-Tcon Surgi, Ez-Tcon Needle, SM ENG CO.,LTD, SM ENG CO.,LTD,
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blade, Scalpel | GES | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Cerclage, Gynecological | HDH | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Neurosurgical Suture | HAS | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Ophthalmic Suturing | HNM | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Suturing, Reusable | GDL | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Tonsil Suturing | KBR | 1 | Manufacturer | accessdata.fda.gov |
| Stapler, Skin | QQS | 1 | Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Silk | GAP | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | 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 |
|---|---|---|---|---|---|---|
| July 7, 2020 | K200392 | REXSIN | GAM | Substantially Equivalent | Sm Eng Co., Ltd. | accessdata.fda.gov |
| December 21, 2018 | K173747 | REXLENE | GAW | Substantially Equivalent | Sm Eng Co., Ltd. | accessdata.fda.gov |
| March 12, 2018 | K173779 | REXMONO, PDREX | GAM | Substantially Equivalent | Sm Eng Co., Ltd. | accessdata.fda.gov |
| March 2, 2017 | K161633 | REXLON, REXSIL | GAR | Substantially Equivalent | Sm Eng Co., Ltd. | accessdata.fda.gov |
| February 10, 2017 | K161629 | CRYLREX | GAM | Substantially Equivalent | Sm Eng Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Suturing, Reusable
- All makers of Needle, Suturing, Disposable
- All makers of Needle, Cerclage, Gynecological
- All makers of Needle, Ophthalmic Suturing
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
- All makers of Suture, Surgical, Absorbable, Polydioxanone
Updated July 7, 2020. 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.