Molli Surgical, Inc.

Molli Surgical, Inc. specializes in three primary device categories: implantable radiological image markers (to improve visibility in imaging), single-use percutaneous-access kits for interventional radiology (for controlled needle or catheter insertion), and frame/rail/pole device holders (to stabilize surgical equipment during procedures). These products support precision and safety in minimally invasive and imaging-guided surgeries.

Molli Surgical, Inc. is headquartered in the United States. Since the FDA regulates medical devices in the U.S., the company’s devices must comply with FDA requirements, including classification under Class I or Class II and registration in the 510(k) and Unique Device Identifier (UDI) systems. The U.S. location influences which regulatory pathways apply, but compliance depends on individual device authorizations, not the company itself.

Molli Surgical, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) pathway is used for Class II devices to demonstrate substantial equivalence to a predicate device, while the UDI system ensures traceability and transparency in the supply chain. These registries help track device performance, compliance, and post-market surveillance, which is critical for patient safety and regulatory oversight.

Molli Surgical, Inc.’s devices fall under FDA Class I (generally low-risk, like some surgical instruments) and Class II (moderate-risk, requiring special controls to ensure safety and effectiveness, such as radiological markers or access kits). Classification determines regulatory scrutiny: Class I devices often require general controls, while Class II may need additional pre-market submissions (like 510(k)s) to prove safety and performance. The classification reflects the device’s risk level and intended use.