Clip, Implantable, Reprocessed
The implantable clip (reprocessed) is a non-absorbable surgical device intended to connect internal tissues to aid in healing. It is classified as FDA Class 2 under regulation 878.4300 in the General and Plastic Surgery specialty, requiring 510(k) clearance before marketing. This device carries an implant flag, indicating it is placed within the body, and reprocessing validation data must be included in the 510(k) submission as required for reprocessed single-use devices. Product code NMJ is not eligible for third-party review.
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Basic Information
- Product Code
- NMJ
- Device Class
- FDA class 2
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K033579 | REPROCESSED MULTIPLE CLIP APPLIERS | Jul 11, 2005 | Substantially Equivalent | Clearmedical, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.