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.
Clearance details
- Applicant
- Intromedic Co., Ltd.
- Product code
- 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
Recent devices under product code NEZ
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- K233229 — NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
- 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.