PuraStat-RM— 510(k) K261504
Substantially Equivalent3-D Matrix, Inc.
FDA 510(k) clearance K261504 for PuraStat-RM, Substantially Equivalent on 2026-08-03. Applicant: 3-D Matrix, Inc.. Device class: Unclassified.
Summary
3-D Matrix filed PuraStat-RM under product code PHN, protective coatings for mucoadhesive application to the rectal mucosa. The record doesn't expand RM.
The device class is listed as U, with no regulation number, and the classification panel is listed as Unknown. The Gastroenterology and Urology review panel handled it as a Traditional 510(k).
3-D Matrix filed from Newton, Massachusetts. FDA found it substantially equivalent 89 calendar days after receipt (May 6 to August 3, 2026).
Clearance details
- Applicant
- 3-D Matrix, Inc.
- Product code
- Product code PHN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newton, MA, US
Recent devices under product code PHN
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