DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System— 510(k) K250411

Substantially Equivalent

Dannik, LLC

FDA 510(k) clearance K250411 for DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System, Substantially Equivalent on 2025-03-12. Applicant: Dannik, LLC.

Clearance details

Applicant: Dannik, LLC
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-13
Decision date: 2025-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winter Park, FL, US

Download summary PDF View on FDA.gov ↗

Adverse 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, 2020-01-01 through 2026-04-23. 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.