K250411
- 510(k) number
- K250411
- Device name
- DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
- Applicant
- Dannik, LLC FL · US
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2025-03-12
- Date received
- 2025-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250411.pdf
Official FDA record: K250411
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.