Regulatory Compliance

Pre-Sure® physical replicas are intended for adjunctive use along with other diagnostic tools and expert clinical judgment for diagnosis, patient management, and/or treatment selection of genitourinary applications.

Pre-Sure® physical replicas are created in soft silicone materials that can be cut, sutured, and in some cases even bleed. These unique capabilities may provide new opportunities for pre-surgical planning and rehearsal.

Please refer to the Pre-Sure® Instructions for Use manual for additional instructions on Pre-Sure®. You can find the FDA clearance document for Pre-Sure® here.

Pre-Sure® is intended for use in diagnosis, patient management, and/or treatment selection. Pre-Sure is covered by billing (CPT) codes issued by the American Medical Association.

Federal law restricts Pre-Sure to sale, distribution and use by, or on the order of, a physician.

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