# K980483: Mentor Suspend Sling

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Apr 30, 1998 after 80 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.
297 later devices descend from it; 7 cite it directly.
0 of 298 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GoreTex™ Tissue Reinforcement Patch: named in the summary without a submission number
- (no number) ProteGen™ Sling: named in the summary without a submission number

## Most influential descendants
- K992159: Surgisis Sling (1999), 204 descendants of its own
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), 173 descendants of its own
- K002721: Ams Triangle Silicone-Coated Sling and Surgical Mesh (2000), 113 descendants of its own
- K020049: Fortaflex Surgical Mesh (2002), 102 descendants of its own
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant (2003), 91 descendants of its own

## Indications for use
The Mentor SUSPEND™ Sling is an implant which is intended to reinforce soft tissue where weakness exists for the urological anatomy inclusive of the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, reconstruction of the pelvic floor, and sacro-culposuspension. It is intended for the treatment of female urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K980483
Methodology: https://510kreport.com/methodology