# K041669: Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSD

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Surgical Innovations
- Decided: Oct 27, 2004 after 128 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K842066 (1985). 11 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030879: Veritas Collagen Matrix, Synovis Surgical Innovations (2003) Summary page 1.
- K040415: Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement, Synovis Surgical Innovations (2004) Summary page 1.

## Most influential descendants
- K083039: Veritas Collagen Matrix (Dry) (2008), 2 descendants of its own
- K192615: Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) (2019), 1 descendant of its own
- K213125: PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (2021), 0 descendants of its own
- K153364: Kerecis SecureMesh (2016), 0 descendants of its own

## Recalls of this device
- Oct 26, 2011 · Not classified · Z-0274-2012: Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled.
- Mar 16, 2007 · Not classified · Z-0965-2007: Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise th
- Mar 16, 2007 · Not classified · Z-0961-2007: Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise th
- Mar 16, 2007 · Not classified · Z-0962-2007: Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise th
- Mar 16, 2007 · Not classified · Z-0963-2007: Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise th
- Mar 16, 2007 · Not classified · Z-0964-2007: Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise th
- Mar 16, 2007 · Not classified · Z-0960-2007: Package Integrity/Sterility Compromised: The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise t
- Nov 1, 2005 · Not classified · Z-0764-06: The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable.

## Indications for use
Veritas Dry 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. Veritas Dry can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures. Veritas Dry can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures. Veritas Dry is intended to be used for reinforcement of suture-lines and staple-lines (for example: occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

Source page: https://510kreport.com/device/K041669
Methodology: https://510kreport.com/methodology