510(k) K173335

Gazelle PTFE and Suture Delivery Device by Dura Tap, LLC — Product Code NBY

K173335 is an FDA 510(k) premarket notification submitted by Dura Tap, LLC for the device "Gazelle PTFE and Suture Delivery Device". The FDA issued a decision of Substantially Equivalent on February 8, 2018. The device falls under product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene), a Class II device regulated under 21 CFR 878.5035. Dura Tap, LLC has at least 1 other 510(k) clearance on record.