K240675
- 510(k) number
- K240675
- Device name
- Endoscopic Injection Needles
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd. CN
- Product code
- FBK — Endoscopic Injection Needle, Gastroenterology-Urolog
- Decision date
- 2024-10-04
- Date received
- 2024-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K240675.pdf
Official FDA record: K240675
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.