# K923657: Supple Peri-Guard

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: Dec 21, 1992 after 208 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
No predicates in its family tree.
414 later devices descend from it; 9 cite it directly.
3 of 415 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K961810: Supple Peri-Guard Pericardium (1996), 409 descendants of its own
- K961811: Peri-Guard Pericardium (1996), 339 descendants of its own
- 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
- K970561: Graft Patch (1997), 285 descendants of its own
- K980431: Surgisis (1998), 284 descendants of its own

Source page: https://510kreport.com/device/K923657
Methodology: https://510kreport.com/methodology