MiroCam® Capsule Endoscope System— 510(k) K252617
Substantially EquivalentIntromedic Co., Ltd.
FDA 510(k) clearance K252617 for MiroCam® Capsule Endoscope System, Substantially Equivalent on 2026-05-08. Applicant: Intromedic Co., Ltd.. Device class: 2.
Summary
Intromedic's MiroCam Capsule Endoscope System is filed under NEZ, wireless capsule gastrointestinal imaging systems.
Class II, 21 CFR 876.1300. Gastroenterology and Urology is both the classification panel and the review panel. It came in as a Special 510(k).
Intromedic filed from Guro-Dong, Guro-Gu, South Korea. Review took 262 calendar days (August 19, 2025 to May 8, 2026).
Clearance details
- Applicant
- Intromedic Co., Ltd.
- Product code
- Product code NEZ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Guro-Dong, Guro-Gu, KR
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- K230991 — PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
More clearances from Intromedic Co., Ltd.
view allAdverse events under product code NEZ
product code NEZ- Death
- 11
- Injury
- 218
- Total
- 229
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.