NMJ — Clip, Implantable, Reprocessed Class II
FDA product code NMJ covers "Clip, Implantable, Reprocessed", a Class II medical device regulated under 21 CFR 878.4300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NMJ
- Device Class
- Class II
- Regulation Number
- 878.4300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
The "implantable clip, reprocessed" is intended to connect internal tissues to aid in healing. It is not absorbable. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K033579 | clearmedical | REPROCESSED MULTIPLE CLIP APPLIERS | July 11, 2005 |