# K040119: Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Surgical Innovations
- Decided: Mar 17, 2004 after 57 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: 7 generations back to K842066 (1985). 21 ancestors in all.
69 later devices descend from it; 3 cite it directly.
0 of 91 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 1.
- K032865: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (2003) Summary page 1.

## Most influential descendants
- K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement (2008), 48 descendants of its own
- K103263: Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology (2010), 45 descendants of its own
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers (2011), 44 descendants of its own
- K062915: Veritas Collagen Matrix (2006), 15 descendants of its own
- K121510: Idrive Ultra Powered Handle Endo Gia Adapter (2012), 8 descendants of its own

## Indications for use
Peri-Strips Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed. Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures. Peri-Strips can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.

Source page: https://510kreport.com/device/K040119
Methodology: https://510kreport.com/methodology