BR SURGICAL LLC

BR Surgical LLC specializes in reusable surgical instruments primarily used for soft-tissue manipulation. Their product range includes surgical scissors (general-purpose and ENT-specific), forceps (both scissors-like and tweezers-like), retractors, needle holders, and speculums (vaginal and ear). These instruments are designed for precision in various surgical procedures, ensuring reliability and durability in clinical settings.

BR Surgical LLC is headquartered in the United States. The company’s location influences its regulatory compliance, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA). This means its devices are subject to FDA regulations, including classification and listing requirements.

BR Surgical LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability in the healthcare supply chain. This listing is part of the company’s compliance with FDA requirements for medical devices.

BR Surgical LLC’s devices are classified as either Class I or Class II medical devices under FDA regulations. Class I devices generally pose the lowest risk and may be exempt from some premarket submissions, while Class II devices require a 510(k) clearance to demonstrate substantial equivalence to a predicate device. The classification depends on factors like the device’s intended use and potential risk to patients.

The 510(k) pathway applies to BR Surgical LLC’s Class II devices, which are determined to carry a moderate risk. This pathway requires manufacturers to submit premarket notifications to the FDA, demonstrating that their device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness. This ensures that new or modified devices meet established standards before entering the market.