K-numberK252957
Device namePneumo Dissector Hook
ApplicantAb Medica Sas
Product codeGCJ
Device classClass II
Decision dateJan 23, 2026
DecisionSubstantially Equivalent
Regulation876.1500
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

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.

Technological characteristics

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.

Test standards cited

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).

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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