FDA.reportPublic FDA data

510(k) K243388

Device
Disposable Distal Cap
Applicant
Micro-Tech (Nanjing) Co., Ltd.
510(k) number
K243388
Product code
FDS
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-27
Date received
2024-10-31
Regulation
876.1500
Classification name
Gastroscope And Accessories, Flexible/Rigid
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Sally He
Address
# 10 Gaoke Third Rd., Nanjing National Hi-Tech Industrial Development Zone Nanjing CN 210032 210032

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FDS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.2026-04-21
K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation2026-02-17
K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFujifilm Corporation2026-02-06
K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)Pentax of America, Inc.2025-12-16
K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100Actuated Medical, Inc.2025-10-31
K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.2025-10-10
K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.2025-06-16
K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFujifilm Corporation2025-06-10
K242635Endoscopic Distal Attachment (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.2025-05-30
K250296Disposable Distal Attachment D-201 SeriesOlympus Medical Systems Corp.2025-05-01
K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)Pentax of America, Inc.2024-12-06
K242779Hood (DH-083ST)Fujifilm Corporation2024-10-11
K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFujifilm Corporation2024-09-04
K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corporation2024-06-19
K232919Ambu® aScope™ Gastro Large; Ambu® aBox™ 2Ambu A/S2024-04-05