Clearance Summary
Injection Needle received FDA 510(k) clearance under submission number K260262, sponsored by Mirco-Tech (Nanjing) Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2026-05-29.
- Submission: K260262
- Applicant / Sponsor: Mirco-Tech (Nanjing) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2026-05-29
Classification & Regulation
This clearance is catalogued under FDA product code FBK and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.