PDW — Internal Tissue Marker Class II

FDA Device Classification

Classification Details

Product Code: PDW
Device Class: Class II
Regulation Number: 878.4670
Submission Type
Review Panel: SU
Medical Specialty: General, Plastic Surgery
Implant: No

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K161507	cianna medical	Cianna Medical SAVI Scout Reflector and SAVI Scout System	July 29, 2016
DEN130004	moerae matrix	MOERAE SURGICAL MARKING PEN	December 18, 2014
K141318	cianna medical	CIANNA MEDICAL SGS SYSTEM	August 27, 2014