FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dannik Titanium Ligation Clip
K Number: K192711
·
Decision Dec 20, 2019
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
5
Review Days
84
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Basic Information
- Device Name
- Dannik Titanium Ligation Clip
- K Number
- K192711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dannik
- Date Received
- September 27, 2019
- Decision Date
- December 20, 2019
- Product Code
- FZP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FZP | Clip, Implantable | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Dannik
| K Number | Device Name | ||
|---|---|---|---|
| K201063 | DANNIK Disposable Monopolar Laparoscopic Instrument | Jun 9, 2020 | Substantially Equivalent |
| K200053 | DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) | Apr 21, 2020 | Substantially Equivalent |
| K193019 | DANNIK Disposable Monopolar Laparoscopic Instrument | Mar 4, 2020 | Substantially Equivalent |
| K192643 | Dannik Laparoscopic Suction Irrigation System | Nov 19, 2019 | Substantially Equivalent |