# K073164: Ivs Tunneller Devices

- Pathway: 510(k) (Traditional)
- Applicant: Covidien UK Manufacturing, Ltd.
- Decided: Mar 5, 2008 after 117 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
Longest line of descent: 1 generation back to K915526 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010035: Ivs Tunneller, United States Surgical, A Division of Tyco Healthc (2001) Summary page 1.
- K991400: Parietene Polypropylene Mesh, Sofradim Production (1999) Summary page 1.
- K915526: Coated Surgipro (TM) Polypropylene Surgical Mesh, United States Surgical, A Division of Tyco Healthc (1992) Summary page 1.

## Indications for use
The IVS Tunneller TM Intra-Vaginal Sling placement device is intended to be used in females to position a polypropylene mesh for the treatment of genuine stress urinary incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse. The Obturator IVS TunnellerTM Intra-Vaginal Sling placement device is intended to be used in females to position a polypropylene mesh for the treatment of genuine stress urinary incontinence (SUI) and for mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K073164
Methodology: https://510kreport.com/methodology