K232826
- 510(k) number
- K232826
- Device name
- Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)
- Applicant
- Steris OH · US
- Product code
- FBK — Endoscopic Injection Needle, Gastroenterology-Urolog
- Decision date
- 2024-03-08
- Date received
- 2023-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K232826.pdf
Official FDA record: K232826
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.