FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SmartClip Delivery Catheter (ADR-1715)
K Number: K260565
·
Decision May 14, 2026
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
1
Review Days
84
Basic Information
- Device Name
- SmartClip Delivery Catheter (ADR-1715)
- K Number
- K260565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elucent Medical
- Date Received
- February 19, 2026
- Decision Date
- May 14, 2026
- Product Code
- EOQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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