510(k) K261504
K261504 is an FDA 510(k) premarket notification submitted by 3-D Matrix, Inc. for the device "PuraStat-RM". The FDA issued a decision of Substantially Equivalent on August 3, 2026. The device falls under product code PHN (Protective Coating, Mucoadhesive Application, For The Rectal Mucosa), a Class U device. 3-D Matrix, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 2026
- Date Received
- May 6, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type
Mucoadhesive application for the protective coating of the rectal mucosa.