DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System— 510(k) K250411
Substantially EquivalentDannik, LLC
FDA 510(k) clearance K250411 for DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System, Substantially Equivalent on 2025-03-12. Applicant: Dannik, LLC. Device class: 2.
Clearance details
- Applicant
- Dannik, LLC
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winter Park, FL, US
Recent devices under product code GCJ
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- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Dannik, LLC
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.