# K961810: Supple Peri-Guard Pericardium

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: Jun 13, 1996 after 34 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: 1 generation back to K921895 (1992). 2 ancestors in all.
409 later devices descend from it; 5 cite it directly.
2 of 412 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921895: Tissue Patch, Tissue Graft, Bio-Vascular, Inc. (1992) Summary page 1.
- K923657: Supple Peri-Guard, Bio-Vascular, Inc. (1992) Summary page 1.

## Most influential descendants
- K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc (1998), 336 descendants of its own
- K980431: Surgisis (1998), 284 descendants of its own
- K992159: Surgisis Sling (1999), 204 descendants of its own
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), 173 descendants of its own
- K992537: Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-Treated (2000), 147 descendants of its own

## Indications for use
For use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).

Source page: https://510kreport.com/device/K961810
Methodology: https://510kreport.com/methodology