# K040415: Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Surgical Innovations
- Decided: Apr 14, 2004 after 56 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K842066 (1985). 9 ancestors in all.
24 later devices descend from it; 4 cite it directly.
1 of 34 devices in its family (counting itself) has 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.
- K983602: CV Peri-Guard and Vascu-Guard, Bio-Vascular, Inc. (1998) Summary page 1.

## Most influential descendants
- K063349: Cormatrix Patch for Cardiac Tissue Repair (2007), 11 descendants of its own
- K140306: Cormatrix Protect Ecm Envelope (2014), 4 descendants of its own
- K041669: Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSD (2004), 4 descendants of its own
- K173242: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (2017), 3 descendants of its own
- K130997: Neoveil (2013), 3 descendants of its own

## Recalls of this device
- Jun 30, 2010 · Not classified · Z-2447-2010: Synovis Surgical Innovations is voluntarily recalling PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix

## 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 be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures. Peri-Strips is intended to be used for reinforcement of suture-lines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

Source page: https://510kreport.com/device/K040415
Methodology: https://510kreport.com/methodology