# Dannik

- Location (FDA's records): Winter Park, FL
- FDA decisions: 8 (2019–2025): 8 510(k) clearances
- Names in FDA's records: Dannik (5); Dannik, LLC (3)
- Product codes: GEI (4), GCJ (3), FZP (1)
- 510(k) review time since 2016: median 102 days, against 105 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ethicon Endo-Surgery, Inc.: 2 (https://510kreport.com/company/ethicon-endo-surgery)
- Unimax Medical Systems, Inc.: 2 (https://510kreport.com/company/unimax-medical-systems)
- Genicon, Inc.: 1 (https://510kreport.com/company/genicon)
- Espiner Medical Limited: 1 (https://510kreport.com/company/espiner-medical)
- Vitalitec Int'L., Inc.: 1 (https://510kreport.com/company/vitalitec-int-l)
- Teleflex Medical: 1 (https://510kreport.com/company/teleflex-medical)
- Hunan Handlike Minimally Invasive Surgery Co., Ltd.: 1 (https://510kreport.com/company/hunan-handlike-minimally-invasive-surgery)

## Firms that cite its devices most
- Thermasolutions, LLC: 1 (https://510kreport.com/company/thermasolutions)

## Its most-cited devices
- K193019: DANNIK Disposable Monopolar Laparoscopic Instrument (2020), cited by 1
- K192643: Dannik Laparoscopic Suction Irrigation System (2019), cited by 1

## Recent decisions
- K250411: DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (Mar 12, 2025)
- K211019: Disposable Monopolar Laparoscopic Tips and Reusable Handles (Oct 28, 2021)
- K210569: Disposable Monopolar Laparoscopic Shafts and Reusable Handles (Aug 16, 2021)
- K201063: DANNIK Disposable Monopolar Laparoscopic Instrument (Jun 9, 2020)
- K200053: DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) (Apr 21, 2020)
- K193019: DANNIK Disposable Monopolar Laparoscopic Instrument (Mar 4, 2020)
- K192711: Dannik Titanium Ligation Clip (Dec 20, 2019)
- K192643: Dannik Laparoscopic Suction Irrigation System (Nov 19, 2019)

Source page: https://510kreport.com/company/dannik