K221054 is an FDA 510(k) clearance for the CORE-INJECTOR. This device is classified as a Endoscopic Injection Needle, Gastroenterology-urology (Class II - Special Controls, product code FBK).
Submitted by Incore Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on December 21, 2022, 254 days after receiving the submission on April 11, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue..
| 510(k) Number | K221054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2022 |
| Decision Date | December 21, 2022 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FBK - Endoscopic Injection Needle, Gastroenterology-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue. |