Hemostasis, LLC

Hemostasis, LLC specialises in haemostatic agents and intranasal splints. Their products include chitosan-based dressings (non-bioabsorbable), plant polysaccharide haemostatic dressings (non-bioabsorbable and non-antimicrobial), synthetic bone wax, and non-biodegradable intranasal splints. These devices are primarily designed to control bleeding in surgical or trauma scenarios, with some also used for nasal fracture management. Examples include PosiSep X dressings, NexStat haemostatic agents, and BoneSeal bone wax.

Hemostasis, LLC is based in the United States. Their devices are authorised under FDA regulations, which classify them as Class I, Class II, or unclassified (U). Many of their products are authorised via the 510(k) pathway—a premarket submission process for demonstrating substantial equivalence to a legally marketed predicate device—and are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device standards.

Hemostasis, LLC’s devices are included in the FDA’s 510(k) registry, which tracks premarket notifications for authorised medical devices, and the FDA’s Unique Device Identifier (UDI) database. These registries ensure transparency and compliance tracking for products like haemostatic dressings, bone wax, and intranasal splints, which are classified under Class I, Class II, or unclassified (U) categories.

Hemostasis, LLC’s devices are classified under three categories: Class I (generally low-risk), Class II (requires special controls to ensure safety and effectiveness), and unclassified (U) for products that do not fit into the standard risk-based classifications. The classification determines the regulatory pathway, such as the 510(k) process for Class II devices, while simpler Class I devices may require less stringent premarket review. This classification system ensures appropriate oversight based on the device’s risk level.