Product code PDW— General, Plastic Surgery

CIANNA MEDICAL SGS SYSTEM

Classification name: Internal Tissue Marker
Device class: Class 2
Regulation: 21 CFR 878.4670
Advisory panel: General, Plastic Surgery
Total cleared: 3
First cleared: 2014-08-27
Most recent: 2016-07-29

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code PDW under 21 CFR 878.4670, via openFDA

Market context for product code PDW

FDA has cleared 3 devices under product code PDW between 2014 and 2016, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20161 clearance
20142 clearances

Top applicants under product code PDW

Cianna Medical, Inc.2 clearances
Moerae Matrix, Inc.1 clearance

Recent clearances under product code PDW

K161507 — Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc.·2016-07-29
DEN130004 — MOERAE SURGICAL MARKING PENMoerae Matrix, Inc.·2014-12-18
K141318 — CIANNA MEDICAL SGS SYSTEMCianna Medical, Inc.·2014-08-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.