# K183622: NasalCEASE and BleedCEASE

- Pathway: 510(k) (Traditional)
- Applicant: Les Laboratoires Brothier S.A.
- Decided: Dec 2, 2019 after 341 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- 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: 6 generations back to K821150 (1982). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102742: Nasal Cease, Catalina, Inc. (2011) Summary page 5.
- K922540: Wound Dressing, Les Laboratorires Brothier, S.A. (1992) Summary page 5.
- K984069: Entaxis Nasal Packing, Les Laboratorires Brothier, S.A. (1999) Summary page 5.

## Indications for use
OTC: For the local management of bleeding wounds such as minor cuts, minor lacerations, minor abrasions, and minor nosebleeds. Prescription: For nasal epistaxis and the local management of topical wounds, including both non-infected and infected: • Small bleeding surface wounds • Small post-surgical incisions • Abrasions and lacerations

Source page: https://510kreport.com/device/K183622
Methodology: https://510kreport.com/methodology