K241523
- 510(k) number
- K241523
- Device name
- injeTAK Adjustable Tip Needle (DIS199; DIS201)
- Applicant
- Laborie Medical Technologies, Corp. NH · US
- Product code
- FBK — Endoscopic Injection Needle, Gastroenterology-Urolog
- Decision date
- 2024-08-27
- Date received
- 2024-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241523.pdf
Official FDA record: K241523
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.