K231622
- 510(k) number
- K231622
- Device name
- REGER Nebulizer Irrigation Cannula
- Applicant
- Reger Medizintechnik, GmbH DE
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2023-09-29
- Date received
- 2023-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231622.pdf
Official FDA record: K231622
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.