510(k) K220846
K220846 is an FDA 510(k) premarket notification submitted by Incore Co., Ltd. for the device "CORE-SNARE". The FDA issued a decision of Substantially Equivalent on November 21, 2022. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Incore Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2022
- Date Received
- March 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Snare, Flexible
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type