510(k) · Cleared
ClearedTigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · GDW Staple, Implantable
Cleared on Dec 26, 2019 as substantially equivalent to K111064 (Laax, Inc., 2011) after a 266-day review. Its family tree reaches back 6 generations to 1985. 1 of the 14 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 26, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K842066 (1985). 13 ancestors in all. No later device cites it as a predicate yet. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 5 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 3 generations backK040415 Peri-Strips Staple Line Reinforcement - Sleeve and Strip…Synovis Surgical Innovations · 2004 · Recalled
- 2 generations backK101961 Tigerpaw SystemLaax, Inc. · 2010
- 1 generation backK111064 Tigerpaw System IILaax, Inc. · 2011 · Recalled (Class I)
- This deviceK190884 TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery…Datascope Corp. · 2019
Class I recalls in this family
- K111064 Tigerpaw System IIdirect predicate · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −5 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −3 | K040415 | Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and… | Synovis Surgical Innovations | 2004 | 1 |
| −2 | K101961 | Tigerpaw System | Laax, Inc. | 2010 | — |
| −1 | K111064 | Tigerpaw System II | Laax, Inc. | 2011 | Class I |
| 0 (this device) | K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool | Datascope Corp. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 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.
1 device in this family has a Class I recall. 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 GDW device
- #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K111064 | Tigerpaw System IISummary page 4…Staple Line Reinforcement Material, FTL Regulation Numbers: 21 CFR 878.4750 21 CFR 870.3470 Predicate Device: (K111064) TigerPaw System II (SE: 11 May 2011) Device Description: The TigerPaw Pro is a flexible, implantable occlusion fastener to… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K111064Tigerpaw System IILaax, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- 4 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GDW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 2025
MAUDE reports naming product code GDW, 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 | 8 | 56 | 9 | 2,401 |
| 2008 | 7 | 57 | 0 | 2,380 |
| 2009 | 13 | 27 | 22 | 4,014 |
| 2010 | 10 | 39 | 2 | 3,768 |
| 2011 | 11 | 49 | 9 | 3,826 |
| 2012 | 9 | 45 | 11 (1) | 3,717 |
| 2013 | 13 | 49 | 1 | 3,777 |
| 2014 | 15 | 63 | 0 | 4,784 |
| 2015 | 8 | 111 | 6 | 4,899 |
| 2016 | 11 | 96 | 2 | 5,106 |
| 2017 | 13 | 103 | 3 | 11,643 |
| 2018 | 7 | 90 | 3 | 14,914 |
| 2019 | 12 | 205 | 4 (4) | 16,600 |
| 2020 | 10 | 88 | 11 | 12,332 |
| 2021 | 9 | 233 | 0 | 13,015 |
| 2022 | 7 | 89 | 0 | 13,605 |
| 2023 | 4 | 267 | 1 | 14,623 |
| 2024 | 2 | — | 0 | 13,280 |
| 2025 | 3 | 111 | 3 | 11,905 |
| 2026 | 3 | 141 | 0 | — |
What is it indicated for?
The TigerPaw Pro is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190884: TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190884
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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