Sign in Sign up

← Every applicant

Hunan Vathin Medical Instrument Co., Ltd. FDA Approvals

0 new drug approvals and 17 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Single-use Flexible Bronchoscope510(k)Sep 23, 2026Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Sep 23, 2026
Vathin® Video Bronchoscope System510(k)Jul 25, 2025Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jul 25, 2025
Single-use Ureteral Access Sheath510(k)Jul 3, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Jul 3, 2025
Single-use Flexible Ureteroscope510(k)May 6, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 6, 2025
Digital Video Processor510(k)Jan 29, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 29, 2025
Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL510(k)Jan 16, 2025Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jan 16, 2025
Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)510(k)Dec 18, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Dec 18, 2024
Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)510(k)Oct 29, 2024Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Oct 29, 2024
Single-use Ureteral Access Sheath510(k)Oct 8, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 8, 2024
Video Ureteroscope System510(k)Oct 4, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Oct 4, 2024
Video Ureteroscope System510(k)Jan 17, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 17, 2024
Single-use Flexible Rhinolaryngoscope; Digital Video Monitor510(k)Jun 14, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jun 14, 2023
Single-Use Flexible Ureteroscope510(k)May 18, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 18, 2023
Vathin® Video Bronchoscope System510(k)May 15, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	May 15, 2023
Single-Use Flexible Cystoscope510(k)Nov 18, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Nov 18, 2022
Single-Use Flexible Rhinolaryngoscope510(k)Nov 18, 2022Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Nov 18, 2022
Vathin Video Bronchoscope System510(k)Feb 28, 2022Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Feb 28, 2022

Related datasets

FDA RecallsWhat the FDA has made companies pull, and how serious.Workplace SafetyOSHA inspections and citations, by company.Congress TradingThe live feed of disclosed transactions.Politician SearchEvery member who files, and what they hold.