The National Medical Products Administration (NMPA) has granted marketing approval to U.S. medical device firm Ethicon LLC for its absorbable regenerated oxidized cellulose hemostatic granules, designated as an innovative product. The approval marks a milestone for Ethicon’s hemostatic portfolio in China’s surgical device market.
Product Details
The approved product comprises two models:
- Model 3013SP: A pre-loaded applicator containing 3g of hemostatic particles made from compacted fine fibers via a patented process, designed for open surgery.
- Model 3123SPEA: An endoscopic administration catheter device compatible with Model 3013SP, enabling use in minimally invasive procedures.
Both models are radiation sterilized for single-use applications. The granules’ unique structure allows rapid absorption and hemostasis in capillary, venule, and arteriole bleeding scenarios.
Application Scenarios
The hemostatic granules are indicated for endoscopic surgeries (excluding ophthalmology, neurosurgery, and urology) when traditional ligation or bleeding control methods are ineffective. The product serves as an auxiliary tool to manage bleeding in procedures where precision and minimal invasiveness are critical.-Fineline Info & Tech
