# K963226: Surgical Fabrics

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 15, 1996 after 88 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.
280 later devices descend from it; 2 cite it directly.
0 of 281 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) Trelex Natural® Mesh: named in the summary without a submission number
- (no number) Supple Peri-Guard®: named in the summary without a submission number
- (no number) Gore-Tex® Soft Tissue Patch: named in the summary without a submission number
- (no number) Marlex® Mesh: named in the summary without a submission number
- (no number) Mersilene® Mesh: 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
- K972651: IN-Sling (1997), 115 descendants of its own
- K980482: Triangle Sling (1998), 114 descendants of its own
- K002721: Ams Triangle Silicone-Coated Sling and Surgical Mesh (2000), 113 descendants of its own

## Indications for use
The proposed Surgical Fabrics are implants which are intended to reinforce soft tissue where weakness exists for the urological, gynecological and gastroenterological anatomy inclusive but not limited to the following procedures: pubourethral support, urethral and vaginal prolapse repair. colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, and sacro-colposuspension.

Source page: https://510kreport.com/device/K963226
Methodology: https://510kreport.com/methodology