Skin Closure Stapler for Cesarean Section Incisions

Yes. The fasteners are made from bioabsorbable polymer and are FDA 510(k) cleared (K131563) for use in gynecologic surgery, including Cesarean sections. The device is manufactured in an ISO 13485 certified facility, and the subcuticular placement eliminates the external tissue trauma associated with percutaneous metal staples, supporting patient comfort and recovery.

For most Cesarean section incisions, the SU-25 is recommended as it handles incisions up to 25 cm with 25 bioabsorbable fasteners. The SU-10, with 10 fasteners for incisions up to 10 cm, is suited for smaller or laparoscopic gynecologic incisions. Both are FDA cleared for gynecologic surgical applications.

Unlike metal staples that pierce the skin surface and require a separate removal procedure, SubQ It! places bioabsorbable fasteners subcutaneously. This eliminates train-track scarring, patient discomfort during removal, and the cost and time of a staple removal visit. Closure speed is comparable to metal staplers — far faster than hand suturing.

No. The SubQ It! fasteners are made from bioabsorbable polymer and are fully absorbed by the body during the natural healing process. This is a key clinical advantage over percutaneous metal staples, which require a scheduled return visit for removal, adding cost and inconvenience for post-cesarean patients.

Yes. SubQ It! holds FDA 510(k) clearance (K131563) specifically for closing incisions in gynecologic surgery, in addition to abdominal, thoracic, orthopedic, and plastic and reconstructive surgery. The manufacturing facility is also ISO 13485 registered, ensuring consistent quality and regulatory compliance for all clinical settings.

SubQ It! provides Instructions for Use (IFU) documentation, in-service training videos, and direct technical support for surgical teams. Distribution support is also available for facilities or distributors seeking to adopt the system. The team can be reached by phone or email during regular business hours for clinical or sales inquiries.