NMJ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Clip, Implantable, Reprocessed

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4300

Medical specialty

General, Plastic Surgery

Flags

Implant

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).

Adverse events (MAUDE)

2012: 90 · 2013: 44 · 2014: 64 · 2015: 11 · 2016: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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