Data / Medical devices / United States / Dannik
Dannik: FDA-registered device maker in Orlando, FL, United States, 4 510(k) clearances
Dannik is registered with the FDA (registration 3015775837) in Orlando, FL, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015775837
- Address
- 3201 East Colonial Drive Suite M3, Orlando, FL, United States, 32803
- Owner or operator
- DANNIK (10061208)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- January 13, 2020
- Registered through
- 2026
- Brand names listed
- DANNIK Disposable Monopolar Instruments, Dannik Poly Specimen Retrieval System, Dannik Specimen Retrieval Systems, Disposable Monopolar Laparoscopic Tips and Reusable Handles, Trocar Cannula System, Trocar Cannula System II
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 12, 2025 | K250411 | DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System | GCJ | Substantially Equivalent | Dannik, LLC | accessdata.fda.gov |
| October 28, 2021 | K211019 | Disposable Monopolar Laparoscopic Tips and Reusable Handles | GEI | Substantially Equivalent | Dannik, LLC | accessdata.fda.gov |
| April 21, 2020 | K200053 | DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) | GCJ | Substantially Equivalent | Dannik | accessdata.fda.gov |
| March 4, 2020 | K193019 | DANNIK Disposable Monopolar Laparoscopic Instrument | GEI | Substantially Equivalent | Dannik | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Laparoscope, General & Plastic Surgery
Updated March 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.