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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-78/
- Published: 2019-01-13T12:00:00.000Z
- Updated: 2026-09-15T00:54:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141067

**DEVICES**

FDA has cleared a **Delta Med** 510(k) for the DeltaVen Closed System Catheter. The peripheral intravenous device has a needle, extension tubing, and an option for a needleless connecter to the catheter. It will be available in a variety of sizes and configurations, including the only 26 gauge safety catheter in the U.S. market, the company says. The device will be distributed by Smiths Medical.

FDA has cleared an **Orthofix International** 510(k) for its new internal fixation system, the G-Beam Fusion Beaming System, intended for use in treating Charcot foot, a debilitating condition where the bones in the foot weaken and collapse. The device is designed to be implanted in the medial and lateral columns of the foot to provide alignment, stabilization and fixation.

**DRUGS**

FDA has approved a Novo Nordisk supplemental NDA for Tresiba (insulin degludec injection) 100 U/mL, 200 U/mL to include data from the DEVOTE safety outcomes study.

FDA has approved an expanded indication for **Novartis**’ Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients aged one year or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).