K233079
- 510(k) number
- K233079
- Device name
- Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)
- Applicant
- Cook Ireland, Ltd. IE
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2024-06-14
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233079.pdf
Official FDA record: K233079
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.