FDA.reportPublic FDA data

Atomizing surgical topical solution applicator

Definition
A sterile, hand-held manual surgical device intended to be used to apply a topical solution (e.g., medication) in the form of a mist/spray onto the mucosal or serosal surface of an exposed surgical site [e.g., during ear/nose/throat (ENT) or laparoscopic surgery]. It consists of a syringe connected to a cannula (e.g., via a Luer-lock), and contains a built-in atomizer. This is a single-use device.
GUDID devices
11
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00801741044076ARISTADavol Inc.AM00052014-09-12
00801741096808ARISTADavol Inc.AM00102016-01-25
10801741044066ARISTADavol Inc.AM00042014-09-12
20801741044063ARISTADavol Inc.AM00042014-09-12
00851450007299HurriChem Device KitTHERMASOLUTIONS, INC.PDT-58002023-05-10
24026704525724PILLINGTELEFLEX INCORPORATEDIPN0066412018-09-15
24026704525731PILLINGTELEFLEX INCORPORATEDIPN0066422018-09-15
00815277021517CuraplexBOUND TREE MEDICAL, LLC670050-KIT2016-12-14
00815277027823CuraplexBOUND TREE MEDICAL, LLC670052-KIT2016-12-14
10801741044073ARISTA™ AH FlexiTip™ XLDavol Inc.AM00052014-09-12
10801741096805ARISTA AH FlexiTip XL-RDavol Inc.AM00102016-01-25