Internal Tissue Marker

PDW · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4670

Classification

FDA Product Code: PDW
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4670
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 0

Source

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