# K101769: Episil

- Pathway: 510(k) (Traditional)
- Applicant: Camurus AB
- Decided: Sep 13, 2011 after 446 days
- Product code: OLR (Oral Wound Dressing)
- 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: 1 generation back to K013056 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013056: Gelclair Concentrated Oral Gel, Sinclair Pharmaceuticals, Ltd. (2001) Summary page 2.

## Indications for use
Episil® has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy).

Source page: https://510kreport.com/device/K101769
Methodology: https://510kreport.com/methodology