510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PDWClass II

Internal Tissue Marker

21 CFR 878.4670 / General, Plastic Surgery
FDA source (opens on fda.gov)

PDW is the FDA product code for Internal Tissue Marker, a class II device type, regulated under 21 CFR 878.4670. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PDW
Device name
Internal Tissue Marker
FDA 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.
Regulation
21 CFR 878.4670
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code PDW

By decision year
3 clearances under product code PDW with a decision year between 2014 and 2016, 2014 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PDW by decision year
YearClearances
20142
20161

Applicants with the most clearances

Product code PDW
Applicants holding the most 510(k) clearances under product code PDW
ApplicantClearances
Cianna Medical, Inc.2
Moerae Matrix, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PDW.