DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)— 510(k) K200053

Substantially Equivalent

Dannik

FDA 510(k) clearance K200053 for DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only), Substantially Equivalent on 2020-04-21. Applicant: Dannik.

Clearance details

Applicant: Dannik
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2020-01-10
Decision date: 2020-04-21
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.