# K982042: Island Biosurgical Bladder Neck Bolstr Model Ibibol.002

- Pathway: 510(k) (Traditional)
- Applicant: Island Biosurgical, Inc.
- Decided: Sep 8, 1998 after 90 days
- Product code: OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Island Biosurgical Bladder Neck Suspension Bolster: named in the summary without a submission number

## Indications for use
The Island Biosurgical, Inc. Bladder Neck Suspension Bolster is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation. This bolster is recommended where the possibility of reduced suture and mesh reaction is desired.

Source page: https://510kreport.com/device/K982042
Methodology: https://510kreport.com/methodology