ACE Cannula
FDA 510(k) clearance K242741 · decided 2025-01-08
Clearance details
- K-number
- K242741
- Device name
- ACE Cannula
- Applicant
- Ace Medical Industry Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-11
- Decision date
- 2025-01-08
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Yangju-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.