# K172060: Capio SLIM Suture Capturing Device

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Nov 3, 2017 after 119 days
- Product code: PWI (Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse)
- Device class: 2
- Regulation: 21 CFR 884.4910
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K931386 (1993). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122459: Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System, Boston Scientific Corporation (2012) Summary page 5.

## Most influential descendants
- K173527: Digitex Delivery Device (2018), 0 descendants of its own

## Recalls of this device
- Jun 27, 2024 · Class II · Z-2452-2024: Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
- Jun 27, 2024 · Class II · Z-2451-2024: Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
- Feb 12, 2018 · Class II · Z-1616-2018: Potential for Capio sutures to break and /or detach.
- Feb 12, 2018 · Class II · Z-1617-2018: Potential for Capio sutures to break and /or detach.

## Indications for use
The Capio™ SLIM Suture Capturing Device is intended for use in general suturing applications during surgery to assist in the placement of suture material in tissues at the operative site. The Capio™ SLIM Suture Capturing Device is to be used with sensory and/or direct visual control. The Capio SLIM Suture Capturing Device is also intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures.

Source page: https://510kreport.com/device/K172060
Methodology: https://510kreport.com/methodology