510(k) K221054
K221054 is an FDA 510(k) premarket notification submitted by Incore Co., Ltd. for the device "CORE-INJECTOR". The FDA issued a decision of Substantially Equivalent on December 21, 2022. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Incore Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2022
- Date Received
- April 11, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Injection Needle, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.