Capio SLIM Suture Capturing Device

• 2 recalls, same reason

  • Ongoing Z-2452-2024 FDA Class II ·initiated 27 Jun 2024
  • Ongoing Z-2451-2024 FDA Class II ·initiated 27 Jun 2024

  Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.

• 2 recalls, same reason

  • Terminated Z-1616-2018 FDA Class II ·initiated 12 Feb 2018
  • Terminated Z-1617-2018 FDA Class II ·initiated 12 Feb 2018

  Potential for Capio sutures to break and /or detach.

510(k) Number

K172060 ↗

FDA product code

PWI

FDA applicant

Boston Scientific Corporation

Device class

Class II

Regulation

21 CFR Part 884.4910

Advisory committee

Obstetrics/Gynecology

FDA decision

SESE Substantially Equivalent

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• What types of surgical procedures is the Capio SLIM Suture Capturing Device designed for, and why is its slim profile important in these settings?

  The Capio SLIM is specifically designed for open surgical procedures in obstetrics/gynecology, particularly for transvaginal repair of pelvic organ prolapse. Its slim profile (with a suture dart carrier diameter of 2.2 mm) is critical because it allows access to tight or difficult-to-reach anatomical locations, such as the pelvic floor, where traditional tools may struggle to navigate.

• Is the Capio SLIM Suture Capturing Device reusable, or is it intended for single-use only? How does this affect its handling and storage?

  The Capio SLIM is explicitly intended for single-use only, as stated in its design and regulatory documentation. This means each device must be discarded after one surgical procedure to maintain sterility and safety. Proper storage should follow the instructions in the included IFU to preserve sterility until use, ensuring no cross-contamination or degradation occurs.

• What regulatory pathway was followed for the Capio SLIM’s FDA clearance, and what does this mean for clinicians or facilities considering its use?

  The Capio SLIM received FDA clearance through a Traditional 510(k) pathway (K172060), determined to be *substantially equivalent* to a predicate device. This means the FDA reviewed it against existing standards (21 CFR 884.4910) to confirm its safety and effectiveness for the intended use—transvaginal repair of pelvic organ prolapse. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though they should always consult the IFU for proper technique.

• How does the Capio SLIM’s design simplify suture placement in complex anatomical areas like the pelvic floor?

  The Capio SLIM streamlines suture placement by combining three steps—throwing, catching, and retrieving suture material—into a single maneuver. Its slim, 2.2 mm diameter dart carrier allows precise navigation through confined spaces, reducing the need for multiple instruments and minimizing trauma to delicate tissues during pelvic floor repairs.

• Are there multiple sizes or models of the Capio SLIM, or is it available in a single configuration?

  The provided data does not specify multiple sizes or models for the Capio SLIM; it is described as a single slim-profile device with a consistent 2.2 mm suture dart carrier diameter. Facilities should confirm the exact configuration in the IFU or with Boston Scientific, as variations (e.g., suture type compatibility) may exist but aren’t detailed here.