Product code PDW

Device name: Internal Tissue Marker
Medical specialty: General, Plastic Surgery
Device class: 2
Regulation number: 878.4670
Review panel: SU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K161507	Cianna Medical SAVI Scout Reflector and SAVI Scout System	Cianna Medical, Inc.	2016-07-29
DEN130004	MOERAE SURGICAL MARKING PEN	Moerae Matrix, Inc.	2014-12-18
K141318	CIANNA MEDICAL SGS SYSTEM	Cianna Medical, Inc.	2014-08-27

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