Dannik Titanium Ligation Clip
FDA 510(k) K192711 · Dannik
510(k) numberK192711
Submission
- Device name
- Dannik Titanium Ligation Clip
- Applicant
- Dannik
Winter Park, FL, US - Received
- September 27, 2019
- Decision date
- December 20, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FZP – Clip, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code FZP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254231 | Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating ClipsFZP · Traditional | Taiwan Surgical Corporation | 07/20/2026SE |
| K253903 | InnoClip Disposable Clip ApplierFZP · Special | Taiwan Surgical Corporation | 12/22/2025SE |
| K253781 | InnoClip Clip ApplierFZP · Special | Taiwan Surgical Corporation | 12/22/2025SE |
| K250643 | Disposable Polymer Ligation ClipsFZP · Traditional | Hangzhou Kangji Medical Instrument Co., Ltd. | 11/20/2025SE |
| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating ClipsFZP · Traditional | Teleflex Medical | 07/03/2025SE |
| K242541 | Gem ZipclipFZP · Traditional | Synovis Micro Companies Alliance A Subsidiary of… | 01/15/2025SE |
| K221495 | SOLID CLIP Single Use Clip ApplierFZP · Traditional | Medscope Biotech Co., Ltd. | 07/18/2024SE |
| K232970 | Hem-o-lok® Ligating ClipsFZP · Traditional | Teleflex Medical | 01/12/2024SE |
| K230966 | angiOCCLUDE Ligating ClipsFZP · Traditional | A2 Medical Systems, LLC | 09/19/2023SE |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special | Ethicon Endo Surgery, LLC | 08/29/2023SE |
More from Ethicon Endo Surgery, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K250411 | DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval SystemGCJ · Traditional | 03/12/2025SE |
| K211019 | Disposable Monopolar Laparoscopic Tips and Reusable HandlesGEI · Traditional | 10/28/2021SE |
| K210569 | Disposable Monopolar Laparoscopic Shafts and Reusable HandlesGEI · Traditional | 08/16/2021SE |
| K201063 | DANNIK Disposable Monopolar Laparoscopic InstrumentGEI · Special | 06/09/2020SE |
| K200053 | DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval…GCJ · Traditional | 04/21/2020SE |
| K193019 | DANNIK Disposable Monopolar Laparoscopic InstrumentGEI · Traditional | 03/04/2020SE |
| K192643 | Dannik Laparoscopic Suction Irrigation SystemGCJ · Traditional | 11/19/2019SE |
Questions and answers
When was Dannik Titanium Ligation Clip cleared by the FDA?
Dannik Titanium Ligation Clip (K192711) received a 510(k) decision of Substantially Equivalent on December 20, 2019, 84 days after the submission was received.
What is the product code of K192711?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.