Pure Global AI
Applicant profile

Wuxi Hisky Medical Technologies Co., Ltd.

United StatesWuxi, CN5 FDA 510(k) clearances
Verified
5
Total clearances
3
Unique product codes
Jun 2018
Earliest clearance
Oct 2025
Latest clearance
Company details
Location
Wuxi, CN
Regulatory footprint
Search Wuxi Hisky Medical Technologies Co., Ltd. across other regulatory registries
ThailandEuropean UnionColombiaVietnamSouth KoreaEcuador
Device class distribution
Clearances by device class
Class 2100.0% of total5 clearances
Recent clearances
Latest 10 FDA 510(k) clearances
Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
Oct 01, 2025
K-Number
K250026
Class
2
Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);
Jul 24, 2025
K-Number
K243711
Class
2
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
Jun 17, 2025
K-Number
K243880
Class
2
Shear Wave Quantificational Ultrasound Diagnostic System
Mar 17, 2020
K-Number
K200136
Class
2
Shear Wave Quantificational Ultrasound Diagnostic System
Jun 22, 2018
K-Number
K173595
Class
2
About this profile

Explore comprehensive applicant profile for Wuxi Hisky Medical Technologies Co., Ltd. through Pure Global AI's free USA medical device database. This company has 5 FDA 510(k) clearances across 3 unique product codes. Their regulatory history spans from Jun 22, 2018 to Oct 01, 2025.

This page provides detailed insights including recent clearances, device class distribution (Class 2: 5), and complete regulatory timeline from the official FDA OpenFDA database. Pure Global AI offers free access to FDA 510(k) clearances from 1976 to present.