Clip, Implantable, Reprocessed
NMJ is the FDA product code for Clip, Implantable, Reprocessed, a class II device type, regulated under 21 CFR 878.4300. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NMJ
- Device name
- Clip, Implantable, Reprocessed
- FDA 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).
- Regulation
- 21 CFR 878.4300
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code NMJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2005 | 1 |
Applicants with the most clearances
Product code NMJ| Applicant | Clearances |
|---|---|
| Clearmedical, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
