CloSYS® Dry Mouth Sensitive Mouth Rinse— 510(k) K250390

Substantially Equivalent

Rowpar Pharmaceuticals, Inc.

FDA 510(k) clearance K250390 for CloSYS® Dry Mouth Sensitive Mouth Rinse, Substantially Equivalent on 2025-05-19. Applicant: Rowpar Pharmaceuticals, Inc..

Clearance details

Applicant: Rowpar Pharmaceuticals, Inc.
Product code: Code LFD
Advisory panel: Unknown
Date received: 2025-02-11
Decision date: 2025-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgewater, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFD

product code LFD

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.