Clip, Implantable, Reprocessed

NMJ · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4300

Classification

FDA Product Code: NMJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4300
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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).

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown