FDA 510(k)

CloSYS® Dry Mouth Sensitive Mouth Rinse

Numéro K : K250390 · 2025-05-19

Date de décision2025-05-19

Code produitLFD

DécisionSubstantially Equivalent

Résumé du dispositif

CloSYS® Dry Mouth Sensitive Mouth Rinse is the device name listed in this FDA 510(k) record. The listed applicant is Rowpar Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K250390. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CloSYS® Dry Mouth Sensitive Mouth Rinse?

CloSYS® Dry Mouth Sensitive Mouth Rinse is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Rowpar Pharmaceuticals, Inc.. The 510(k) number is K250390.

When did CloSYS® Dry Mouth Sensitive Mouth Rinse receive FDA 510(k) clearance?

CloSYS® Dry Mouth Sensitive Mouth Rinse received FDA 510(k) clearance on 2025-05-19, under 510(k) number K250390.

Who is the listed applicant for CloSYS® Dry Mouth Sensitive Mouth Rinse?

The FDA 510(k) record lists Rowpar Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CloSYS® Dry Mouth Sensitive Mouth Rinse?

The FDA product code for CloSYS® Dry Mouth Sensitive Mouth Rinse is LFD.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositifs connexes (Code : LFD)

K253778Allday Moisturizing RinseElevate Oral Care K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.K234015Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLC K202689Dentilube SprayOxy2plus, LLC K203567Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.