FDA 510(k) Applications for Medical Device Product Code: HDX (Dilator, Vaginal)

FDA 510(k) Applications for Medical Device Product Code "HDX"
(Dilator, Vaginal)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K003380	BIOTEQUE AMERICA, INC.	BIOTEQUE VAGINAL DILATOR	01/29/2001
K071754	KARL STORZ ENDOSCOPY-AMERICA, INC.	NEO-VAGINA SURGERY SET AND ACCESSORIES	01/07/2009
K233689	Lujena, Inc.	Hope&Her Vaginal Dilators	05/02/2024
K222492	Lujena, Inc.	Hope&Her Vaginal Dilators	06/27/2023
K211959	Materna Medical	Milli Vaginal Dilator	12/01/2021
K220035	Materna Medical	Milli Vaginal Dilator	02/27/2023
K130273	Panpac Medical Corporation	PANPAC VAGINAL DILATORS	08/08/2013
K241748	Plus EV Holdings dba Intimate Rose	Intimate Rose Vaginal Dilators	08/14/2024
K231430	Plus EV Holdings dba Intimate Rose	Intimate Rose Vaginal Dilators	06/07/2023