# K140558: Proctigard

- Pathway: 510(k) (Traditional)
- Applicant: Access Pharmaceuticals, Inc.
- Decided: Jul 16, 2014 after 133 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: 3 generations back to K964852 (1997). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062795: Mugard Mucoadhesive Oral Wound Rinse, Access Pharmaceuticals, Inc. (2006) Summary page 1.

## Most influential descendants
- K213552: PuraStat-RM (2022), 3 descendants of its own
- K242634: PuraStat (2025), 2 descendants of its own
- K253923: PuraStat (2026), 1 descendant of its own
- K261504: PuraStat-RM (2026), 0 descendants of its own

## Indications for use
ProcticardTM is indicated for the symptomatic management of rectal mucositis.

Source page: https://510kreport.com/device/K140558
Methodology: https://510kreport.com/methodology