Fast Wound Closure Stapler for Emergency Departments

No. The fasteners are made from a bioabsorbable polymer, meaning they are naturally absorbed by the body as the wound heals. There is no follow-up removal procedure required, reducing patient inconvenience, eliminating associated clinical costs, and improving overall patient experience compared to both metal staples and non-absorbable sutures.

The SubQ It! staplers hold FDA 510(k) clearance (K131563) for closing incisions in abdominal, thoracic, gynecologic, orthopedic, plastic, and reconstructive surgery. They are well-suited for laparoscopic trocar incisions, cesarean sections, inguinal hernia repairs, laparoscopic cholecystectomy, and minimally invasive surgery incisions up to 25 cm.

The SU-10 is preloaded with 10 bioabsorbable fasteners and is designed for smaller incisions up to 10 cm, making it ideal for laparoscopic trocar sites and minor procedures. The SU-25 contains 25 fasteners and accommodates incisions up to 25 cm, suiting larger open surgical wounds such as abdominal and orthopedic incisions. Both deploy each fastener in 7 seconds.

Each SubQ It! fastener deploys in approximately 7 seconds, compared to roughly 42 seconds per stitch with manual suturing technique. This makes the SubQ It! system approximately 7 times faster than manual sutures, significantly reducing operative closure time, minimizing anesthesia exposure, and lowering overall procedure costs.

Yes. Both the SU-10 and SU-25 come pre-sterilized and preloaded with fasteners, sealed in a foil laminate pouch for sterile integrity. No additional preparation is required, enabling immediate use in the operating room and simplifying sterile field management for perioperative nursing teams.

The SubQ It! stapler incorporates a safety tab, an automatic needle retraction mechanism, and a safety stop feature. These safeguards prevent accidental deployment outside the operative field, protect clinical staff from needle-stick injury, and ensure precise, controlled fastener placement with each use, meeting bioabsorbable medical device safety standards.