# K991296: Tutopatch

- Pathway: 510(k) (Traditional)
- Applicant: Tutogen Medical U.S., Inc.
- Decided: Oct 6, 2000 after 540 days
- Product code: FTM (Mesh, Surgical)
- 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
Longest line of descent: 3 generations back to K842066 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc, Bio-Vascular, Inc. (1998) Summary page 3.

## Indications for use
Tutopatch bovine pericardium is intended for use to reinforce soft tissue where weakness exists in general and plastic surgery applications and is indicated for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, repair of rectal prolapse using an abdominal approach (excluding rectocele), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, ventral, scrotal, and umbilical).

Source page: https://510kreport.com/device/K991296
Methodology: https://510kreport.com/methodology