510(k) DEN130004
DEN130004 is an FDA 510(k) premarket notification submitted by Moerae Matrix, Inc. for the device "MOERAE SURGICAL MARKING PEN". The FDA issued a decision of De Novo Granted on December 18, 2014. The device falls under product code PDW (Internal Tissue Marker), a Class II device regulated under 21 CFR 878.4670. Moerae Matrix, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 18, 2014
- Date Received
- May 6, 2013
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Internal Tissue Marker
- Device Class
- Class II
- Regulation Number
- 878.4670
- Review Panel
- SU
- Submission Type
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.