PDW · Class II · 21 CFR 878.4670

FDA Product Code PDW: Internal Tissue Marker

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.

Leading manufacturers include Cianna Medical, Inc. and Moerae Matrix, Inc..

3
Total
2
Cleared
249d
Avg days
2014
Since

FDA 510(k) Cleared Internal Tissue Marker Devices (Product Code PDW)

3 devices
1–3 of 3
Cleared Jul 29, 2016
Cianna Medical SAVI Scout Reflector and SAVI Scout System
K161507
Cianna Medical, Inc.
Radiology · 58d
Not Cleared Dec 18, 2014
MOERAE SURGICAL MARKING PEN
DEN130004
Moerae Matrix, Inc.
General & Plastic Surgery · 591d
Cleared Aug 27, 2014
CIANNA MEDICAL SGS SYSTEM
K141318
Cianna Medical, Inc.
Radiology · 99d

About Product Code PDW - Regulatory Context