510(k) K183289
K183289 is an FDA 510(k) premarket notification submitted by Finemedix Co., Ltd. for the device "ClearGrasp Snare". The FDA issued a decision of Substantially Equivalent on March 6, 2019. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Finemedix Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2019
- Date Received
- November 26, 2018
- 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