# K010035: Ivs Tunneller

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Apr 4, 2001 after 90 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
86 later devices descend from it; 3 cite it directly.
0 of 87 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
- K040537: Ams Apogee Vault Suspension System (2004), 70 descendants of its own
- K050445: Ams Collagen Dermal Matrix (2005), 30 descendants of its own
- K071512: Gynecare Prolift +M* Pelvic Floor Repair Systems (2008), 20 descendants of its own
- K051485: Ams Pelvic Floor Repair System (2005), 17 descendants of its own
- K092207: Restorelle Polypropylene Mesh (2009), 13 descendants of its own

Source page: https://510kreport.com/device/K010035
Methodology: https://510kreport.com/methodology