K261504
- 510(k) number
- K261504
- Device name
- PuraStat-RM
- Applicant
- 3-D Matrix, Inc. MA · US
- Product code
- PHN — Protective Coating, Mucoadhesive Application, For Th
- Decision date
- 2026-08-03
- Date received
- 2026-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261504.pdf
Official FDA record: K261504
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.