# K261504: PuraStat-RM

- Pathway: 510(k) (Traditional)
- Applicant: 3-D Matrix, Inc.
- Decided: Aug 3, 2026 after 89 days
- Product code: PHN (Protective Coating, Mucoadhesive Application, For The Rectal Mucosa)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K964852 (1997). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213552: PuraStat-RM, 3-D Matrix, Inc. (2022) Summary page 5.
- K242634: PuraStat, 3-D Matrix Europe SAS (2025) Summary page 5.
- K253923: PuraStat, 3-D Matrix Europe SAS (2026) Summary page 5.

## Indications for use
PuraStat-RM is indicated for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.

Source page: https://510kreport.com/device/K261504
Methodology: https://510kreport.com/methodology