Data / Medical devices / South Korea / Incore Co., Ltd.
Incore Co., Ltd.: FDA-registered device maker in Daegu, South Korea, 4 510(k) clearances
Incore Co., Ltd. is registered with the FDA (registration 3017390965) in Daegu, South Korea. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 21, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017390965
- Address
- 11, Hyeoksin-daero 78-gil, Dong-gu, Daegu, South Korea, 41072
- Owner or operator
- INCORE Co., Ltd. (10075609)
- Roles
- Manufacturer
- First device listed
- June 20, 2020
- Registered through
- 2026
- Brand names listed
- Becagel, CELRETA, CORE-CLIP, CORE-INJECTOR, CORE-MEDIUM, CORE-SNARE, CORE-SWAB, CORE-Trocar and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Sterile | KDT | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Manufacturer | accessdata.fda.gov |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 2 | Manufacturer | accessdata.fda.gov |
| Hemostatic Metal Clip For The Gi Tract | PKL | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Snare, Flexible | FDI | 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 |
|---|---|---|---|---|---|---|
| December 21, 2022 | K221054 | CORE-INJECTOR | FBK | Substantially Equivalent | Incore Co., Ltd. | accessdata.fda.gov |
| November 21, 2022 | K220846 | CORE-SNARE | FDI | Substantially Equivalent | Incore Co., Ltd. | accessdata.fda.gov |
| June 23, 2022 | K213338 | CORE-CLIP | PKL | Substantially Equivalent | Incore Co., Ltd. | accessdata.fda.gov |
| June 21, 2022 | K211148 | CORE-Trocar | GCJ | Substantially Equivalent | Incore Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Endoscopic Injection Needle, Gastroenterology-Urology
- All makers of Snare, Flexible
- All makers of Hemostatic Metal Clip For The Gi Tract
- All makers of Dressing, Wound, Occlusive
- All makers of Applicator, Absorbent Tipped, Sterile
Updated December 21, 2022. 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.