# K032893: Shelhigh NO-React Biocuff

- Pathway: 510(k) (Traditional)
- Applicant: Shelhigh, Inc.
- Decided: Dec 19, 2003 after 93 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) Shelhigh No-React® pericardial patches: named in the summary without a submission number

## Indications for use
The EnCuff is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a non resorbable scaffold to assist with a soft tissue repair. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, to the supraspinatus, during rotator cuff repair surgery.

Source page: https://510kreport.com/device/K032893
Methodology: https://510kreport.com/methodology