510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130004Unknown

Moerae Surgical Marking Pen

Moerae Matrix, Inc., North Brunswick NJ / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN130004 is the FDA 510(k) clearance record for MOERAE SURGICAL MARKING PEN, a class II device, cleared for Moerae Matrix, Inc. on under FDA product code PDW (Internal Tissue Marker). FDA's definition for product code PDW 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". FDA records list 2 510(k) clearances for Moerae Matrix, Inc., from to . As of , FDA records show no recalls naming DEN130004.

Clearance record

Decision date
Received
(591 days to decision)
Product code
PDW Internal Tissue Marker
Regulation
21 CFR 878.4670
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Moerae Matrix, Inc. 675 Us Hwy. 1, North Brunswick NJ
Third party review
No

Clearances, product code PDW

Trailing 12 months

FDA records hold no clearances under product code PDW in the trailing twelve months.

FDA records show no clearances under product code PDW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PDW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260