NMJ

Clip, Implantable, Reprocessed

Product code

NMJ

Device name

Clip, Implantable, Reprocessed

Device class

Class 2

21 CFR

21 CFR 878.4300

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

1

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).