510(k) · Cleared
ClearedPeri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synovis Life Technologies, Inc. (Baxter International Inc.) · FTM Mesh, Surgical
Cleared on Dec 17, 2019 as substantially equivalent to K041669 (Synovis Surgical Innovations, 2004) and 1 other predicate after an 85-day review. Its family tree reaches back 10 generations to 1985. 1 later device descends from it.
- Decided
- Dec 17, 2019
- Review
- 85 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K842066 (1985). 46 ancestors in all, the oldest K810428 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 6 generations between
- 3 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 2 generations backK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
- 1 generation backK083039 Veritas Collagen Matrix (Dry)Synovis Surgical Innovations · 2008
- This deviceK192615 Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip…Synovis Life Technologies, Inc. (Baxter International Inc.) · 2019
- Descendant · cites it directly · 0 of its ownK213125 PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen…Synovis Life Technologies. Inc. (A Subsidiary of Baxter · 2021
Show all 10 generations
- Root · 10 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 9 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 8 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 7 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 6 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 5 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 4 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 3 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 2 generations backK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
- 1 generation backK083039 Veritas Collagen Matrix (Dry)Synovis Surgical Innovations · 2008
- This deviceK192615 Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip…Synovis Life Technologies, Inc. (Baxter International Inc.) · 2019
Most influential descendants
Showing 1 of 1 · See all- K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −9 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −8 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −7 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −6 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −5 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −4 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −2 | K062915 | Veritas Collagen Matrix | Synovis Surgical Innovations | 2006 | 1 |
| −1 | K083039 | Veritas Collagen Matrix (Dry) | Synovis Surgical Innovations | 2008 | — |
| 0 (this device) | K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology… | Synovis Life Technologies, Inc. (Baxter International Inc.) | 2019 | — |
| +1 | K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with… | Synovis Life Technologies. Inc. (A Subsidiary of Baxter | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041669 | Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSummary page 4…Product Code: FTM, OXE III. PREDICATE DEVICES Primary Predicate: PERI-STRIPS Dry with VERITAS Collagen Matrix Staple Line Reinforcement, K041669 Additional Predicate: PERI-STRIPS Dry Circular Staple Line Reinforcement with VERITAS Collagen Matrix, K083… | 2004 |
| * | K083039 | Veritas Collagen Matrix (Dry)Summary page 4…ix Staple Line Reinforcement, K041669 Additional Predicate: PERI-STRIPS Dry Circular Staple Line Reinforcement with VERITAS Collagen Matrix, K083039 IV. DEVICE DESCRIPTION PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP… | 2008 |
| † | K002233 | Bvi Sling | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP… | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 46 ancestors have a recall of any class.
- Of its descendants, K213125 (Synovis Life Technologies. Inc. (A Subsidiary of Baxter, 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K041669.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon and colorectal procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192615: Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192615
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026