Subcuticular Stapler for Trocar Site Closure

Yes. SubQ It! holds FDA 510(k) clearance (K131563) for closing incisions in abdominal, thoracic, gynecologic, orthopedic, plastic, and reconstructive surgery. This includes trocar incisions made during minimally invasive and laparoscopic surgical procedures, making it a regulatory-compliant option for MIS trocar site closure.

SubQ It! is FDA cleared for abdominal, thoracic, gynecologic, orthopedic, and plastic and reconstructive surgery. Specific applications include laparoscopic cholecystectomy, Cesarean sections, inguinal hernia repair, and minimally invasive trocar site closures. It is suitable for incisions up to 10 cm (SU-10) or 25 cm (SU-25).

Yes, all SubQ It! fasteners are made from a bioabsorbable polymer and do not require removal. They are absorbed naturally by the body after the wound has healed. This eliminates the need for a follow-up removal appointment, reduces patient discomfort, and lowers overall healthcare costs associated with staple removal procedures.

The SU-10 contains 10 bioabsorbable fasteners and is designed for incisions up to 10 cm in length, making it ideal for smaller laparoscopic and trocar site closures. The SU-25 contains 25 fasteners and accommodates incisions up to 25 cm, suited for larger open or combined surgical closures. Both models deploy fasteners in 7 seconds each.

SubQ It! deploys each bioabsorbable fastener in approximately 7 seconds, compared to an average of 42 seconds per stitch with manual sutures. This makes SubQ It! approximately 7 times faster than traditional suturing, significantly reducing closure time in the OR and contributing to lower overall surgical costs and improved workflow efficiency.

Yes. Both the SU-10 and SU-25 models come pre-sterilized and pre-loaded with bioabsorbable fasteners, sealed in a foil laminate pouch for sterile integrity. The device includes safety features such as a safety tab, automatic needle retraction, and a safety stop mechanism to ensure safe and reliable handling during surgical procedures.