# K940205: Peri-Strips

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: May 2, 1994 after 108 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.
151 later devices descend from it; 3 cite it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K971048: Peri-Strips Dry - Staple Line Reinforcement (1997), 148 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
- K014183: Afb (Absorbable Foam Buttress) (2002), 145 descendants of its own
- K030782: Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 143 descendants of its own
- K032865: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 102 descendants of its own

Source page: https://510kreport.com/device/K940205
Methodology: https://510kreport.com/methodology