510(k) K232200
K232200 is an FDA 510(k) premarket notification submitted by Ningbo Xinwell Medical Technology Co., Ltd. for the device "Disposable Injection Needles". The FDA issued a decision of Substantially Equivalent on April 12, 2024. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Ningbo Xinwell Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2024
- Date Received
- July 25, 2023
- 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.