FDA-Cleared Bioabsorbable Skin Stapler for Hospitals

Yes. SubQ It! received FDA 510(k) clearance (K131563) for closing incisions in abdominal, thoracic, gynecologic, orthopedic, plastic, and reconstructive surgery. The manufacturing facility is also ISO 13485 registered, ensuring the device meets rigorous international quality management standards for medical devices.

SubQ It! is FDA cleared for abdominal, thoracic, gynecologic, orthopedic, plastic, and reconstructive surgery. It is specifically suited for laparoscopic trocar incisions, Cesarean sections, inguinal hernia repairs, laparoscopic cholecystectomy, and other minimally invasive surgery (MIS) procedures requiring fast, cosmetically superior skin closure.

Unlike metal staples that pierce external skin and require a separate removal procedure, SubQ It! places bioabsorbable fasteners subcutaneously — eliminating train-track scarring, patient discomfort, and return-visit costs. Closure with SubQ It! is 7X faster than manual sutures and avoids all costs associated with metal staple removal, making it more efficient and cost-effective.

The SU-10 is loaded with 10 bioabsorbable fasteners and is ideal for smaller incisions up to 10 cm, such as laparoscopic trocar sites. The SU-25 contains 25 fasteners and accommodates longer incisions up to 25 cm, making it suitable for more extensive open abdominal, orthopedic, or reconstructive procedures. Both models deploy in 7 seconds per fastener.

No. Because SubQ It! fasteners are bioabsorbable, they are naturally broken down and absorbed by the body after the incision heals. This eliminates the need for a follow-up staple removal visit, reducing both patient burden and hospital administrative costs, while also improving patient experience and compliance with post-operative care.

Yes. SubQ It! is available in the USA and globally through distribution partnerships. The SU-10 model lists global availability, and the company actively supports distribution opportunities internationally. The European Patent Office has also issued a patent (EP 2,762,089) for the technology. Contact the sales team at sales@subq-it.com for distributor inquiries.