# K002233: Bvi Sling

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: Oct 13, 2000 after 81 days
- Product code: PAJ (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K122306: Synovis Collagen Matrix (TBD) (2013), 0 descendants of its own

## Recalls of this device
- Dec 11, 2002 · Not classified · Z-0352-03: A gap in the exterior seal may lead to sterility concerns with the interior pouch.

Source page: https://510kreport.com/device/K002233
Methodology: https://510kreport.com/methodology