Product code NVH
- Device name
- Suture, Knot, Mechanical
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4300
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- In approximation and/or ligation of soft tissue
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051488 | MEDICINELODGE ZIPKNOT | Medicinelodge, Inc. | 2005-07-27 |