K243388
- 510(k) number
- K243388
- Device name
- Disposable Distal Cap
- Applicant
- Micro-Tech (Nanjing) Co., Ltd. CN
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-06-27
- Date received
- 2024-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K243388.pdf
Official FDA record: K243388
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.