| K-number | K252957 |
| Device name | Pneumo Dissector Hook |
| Applicant | Ab Medica Sas |
| Product code | GCJ |
| Device class | Class II |
| Decision date | Jan 23, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The Pneumo Dissector Hook is a surgical instrument that delivers pressurized CO2 gas to separate and dissect soft tissue planes during endoscopic, laparoscopic, and open surgical procedures. It combines a monopolar electrosurgical hook with a CO2 delivery nozzle and consists of a handle with a push-button CO2 activation control and an interchangeable insert available in lengths of 200–330 mm and diameters of 3.5–5.0 mm.
The device is a monopolar hook with integrated CO2 gas delivery at 60 PSI maximum pressure, stainless steel shaft construction, ethylene oxide sterilization, and an external pressure regulator. It differs from the primary predicate (Cook CO2 Pneumo Dissector) in handle design (push-button vs. trigger) and from secondary predicates in using CO2 gas rather than pressurized fluid for dissection.
ISO 11135 (ethylene oxide sterilization validation), ISO 11607-1 (sealing validation for sterile packaging), ASTM F1980 (accelerated aging of packaging), ASTM D4169-16 (transport simulation), and AAMI TIR-30 (protein and hemoglobin residue guidelines for cleaning validation).
View the full FDA submission: accessdata.fda.gov