510(k) K252436

Tula Tympanostomy Tube Delivery Device by Tusker Medical, Inc. — Product Code ETD

K252436 is an FDA 510(k) premarket notification submitted by Tusker Medical, Inc. for the device "Tula Tympanostomy Tube Delivery Device". The FDA issued a decision of Substantially Equivalent on April 23, 2026. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Tusker Medical, Inc. has at least 1 other 510(k) clearance on record.