
Elucent Medical
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SmartClip Delivery Catheter (ADR-1715) is an FDA 510(k)-cleared medical device (K260565) manufactured by Elucent Medical. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 13, 2026. Regulation: 8.

Ansell
SKU MSC846624

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SKU K014192

McKesson
SKU VM-1270030

Hollister
SKU VM-1270031