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NMJClass II

Clip, Implantable, Reprocessed

21 CFR 878.4300 / General, Plastic Surgery

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 year
1 clearance under product code NMJ with a decision year between 2005 and 2005, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NMJ by decision year
YearClearances
20051

Applicants with the most clearances

Product code NMJ
Applicants holding the most 510(k) clearances under product code NMJ
ApplicantClearances
Clearmedical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code