SmartClip Delivery Catheter (ADR-1715)— 510(k) K260565
Substantially EquivalentElucent Medical
FDA 510(k) clearance K260565 for SmartClip Delivery Catheter (ADR-1715), Substantially Equivalent on 2026-05-14. Applicant: Elucent Medical. Device class: 2.
Summary
Elucent Medical's SmartClip Delivery Catheter (ADR-1715) is filed under EOQ, flexible or rigid bronchoscopes.
Class II, 21 CFR 874.4680. The Anesthesiology review panel handled it as a Traditional 510(k), though the record lists Ear, Nose, Throat as the classification panel.
Elucent filed from Eden Prairie, Minnesota. Review took 84 calendar days (February 19 to May 14, 2026).
Clearance details
- Applicant
- Elucent Medical
- Product code
- Product code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Recent devices under product code EOQ
view allAdverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.