Bioabsorbable Wound Closure Stapler for Hernia Repair

Yes. SubQ It! holds FDA 510(k) clearance (K131563) for closing incisions in abdominal, thoracic, gynecologic, orthopedic, plastic, and reconstructive surgery. This includes inguinal hernia repair and trocar incision closure in laparoscopic and minimally invasive surgery (MIS). The manufacturing facility is also ISO 13485 registered.

The bioabsorbable polymer fasteners used in SubQ It! are designed to be absorbed by the body after the wound has healed. The exact absorption timeline depends on individual patient physiology and incision depth, but the material is engineered to maintain wound closure integrity during the critical healing period before safely breaking down within the body.

The SU-10 contains 10 fasteners and is designed for incisions up to 10 cm, making it ideal for trocar sites and smaller laparoscopic incisions. The SU-25 contains 25 fasteners and accommodates incisions up to 25 cm, suited for larger abdominal or reconstructive procedures. Both models are pre-sterilized and feature retractable needle safety mechanisms.

Unlike metal staplers, SubQ It! places fasteners subcutaneously so external skin is never pierced, eliminating train-track scarring. The bioabsorbable fasteners do not require a removal visit, reducing patient discomfort and post-operative care costs. Closure speed is comparable to metal staplers — 7X faster than manual sutures — with significantly better cosmetic outcomes.

SubQ It! is designed for intuitive use by trained surgical professionals. The company provides In-Service Training Videos and Instructions for Use (IFU) documentation with every unit. Technical support is also available. Distribution partners receive dedicated support resources to facilitate training and adoption in hospital and surgical center environments.

Yes. While SubQ It! products are FDA cleared for the US market, Opus KSD, Inc. actively supports global distribution opportunities. The SU-10 model lists global availability. The company holds European Patent Office approval (EP 2,762,089) and has presented at international surgical conferences. Contact the sales team at sales@subq-it.com for international distribution inquiries.