HISTO S.A.

Histo S.A. specializes in mechanical biopsy tools and related accessories. Their primary products include biopsy gun handpieces, some designed with side-notch needles for precise tissue sampling. They also produce single-use spinal needles and implantable radiological image markers, such as the MAMAWIRE FIX, which help guide procedures by marking anatomical locations during imaging. The company’s most recognizable line is the BIOCORE II series, which serves diagnostic biopsy applications.

Histo S.A. is based in the United States. Since they operate domestically, their devices must comply with U.S. regulatory requirements for medical device authorisation. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, which supports traceability and ensures alignment with U.S. regulatory standards for device tracking and compliance.

Histo S.A.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorised for use in the U.S., ensuring transparency in device traceability and compliance with regulatory requirements. Listing in the UDI database is particularly important for Class I devices, as it helps maintain oversight of their distribution and use.

Histo S.A.’s devices fall under Class I classification, which is assigned to products posing low to moderate risk. This classification is determined based on factors like the device’s intended use, potential harm if misused, and the body’s interaction with it. Class I devices typically require less stringent regulatory oversight compared to higher-risk classes, though compliance with manufacturing and labelling standards remains essential for authorisation.