K260262
- 510(k) number
- K260262
- Device name
- Injection Needle
- Applicant
- Mirco-Tech (Nanjing) Co., Ltd. CN
- Product code
- FBK — Endoscopic Injection Needle, Gastroenterology-Urolog
- Decision date
- 2026-05-29
- Date received
- 2026-01-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K260262.pdf
Official FDA record: K260262
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.