# K971048: Peri-Strips Dry - Staple Line Reinforcement

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: May 9, 1997 after 49 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 K940205 (1994). 2 ancestors in all.
148 later devices descend from it; 2 cite it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942583: Peri-Strips Planar Configuration Staple Line Reinforcement, Bio-Vascular, Inc. (1994) Summary page 1.
- K940205: Peri-Strips, Bio-Vascular, Inc. (1994) Summary page 1.

## Most influential descendants
- 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
- K043056: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2004), 77 descendants of its own

## Indications for use
intended to reinforce staple lines during lung and bronchus resections including; pneumonectomy, pneumoreduction, pneumectomy, segmentectomies (segmental resections) wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions and excisions of lung and bronchus.

Source page: https://510kreport.com/device/K971048
Methodology: https://510kreport.com/methodology