510(k) K252617 · NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
MiroCam® Capsule Endoscope System
| Applicant | Intromedic Co., Ltd., Guro-Dong, Guro-Gu, KR |
| Decision | Substantially Equivalent, May 8, 2026 |
| Received | Aug 19, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252617
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.