# K021835: Brennen Medical Surgical Mesh, Glucamesh/Glucatex

- Pathway: 510(k) (Traditional)
- Applicant: Brennen Medical, Inc.
- Decided: Oct 17, 2002 after 135 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.
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) Prolene Soft (Polypropylene): named in the summary without a submission number
- (no number) Mersilene (Polyester): named in the summary without a submission number
- (no number) Biomesh (polypropylene): named in the summary without a submission number

## Indications for use
GlucameshTM/GlucatexTM Surgical Mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse. The meshes are biocompatible and not biodegradable. The device is intended to be implanted by a qualified surgeon.

Source page: https://510kreport.com/device/K021835
Methodology: https://510kreport.com/methodology