K252617
- 510(k) number
- K252617
- Device name
- MiroCam® Capsule Endoscope System
- Applicant
- Intromedic Co., Ltd. KR
- Product code
- NEZ — System, Imaging, Gastrointestinal, Wireless, Capsule
- Decision date
- 2026-05-08
- Date received
- 2025-08-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252617.pdf
Official FDA record: K252617
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.