Cimilre Dual Max— 510(k) K260643
Substantially EquivalentCimilre Co., Ltd.
FDA 510(k) clearance K260643 for Cimilre Dual Max, Substantially Equivalent on 2026-08-21. Applicant: Cimilre Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Cimilre Co., Ltd.
- Product code
- Code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cheonan-Si, Chungcheongnam-Do,, KR
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More clearances from Cimilre Co., Ltd.
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
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.