FDA.reportPublic FDA data

510(k) K261504

Device
PuraStat-RM
Applicant
3-D Matrix, Inc.
510(k) number
K261504
Product code
PHN
Decision
Substantially Equivalent (SESE)
Decision date
2026-08-03
Date received
2026-05-06
Classification name
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Alan Miskewicz
Address
1234 Chestnut St., Suite 205 Newton MA US 02464 02464

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PHN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253923PuraStat3-D Matrix Europe SAS2026-01-07
K242634PuraStat3-D Matrix Europe SAS2025-01-15
K213552PuraStat-RM3-D Matrix, Inc.2022-04-01
K140558PROCTIGARDAccess Pharmaceuticals, Inc.2014-07-16