510(k) · Cleared

Cleared

Tigerpaw System

K101961510(k) TraditionalCleared Oct 29, 2010109-day reviewClass II21 CFR 878.4750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Laax, Inc. · GDW Staple, Implantable

Cleared on Oct 29, 2010 as substantially equivalent to K032696 (United States Surgical, A Division of Tyco Healthc, 2003) and 1 other predicate after a 109-day review. Its family tree reaches back 4 generations to 1985. 1 of the 14 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: Oct 29, 2010
Review: 109 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K842066 (1985). 11 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
3 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
2 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
1 generation backK040415 Peri-Strips Staple Line Reinforcement - Sleeve and Strip…Synovis Surgical Innovations · 2004 · Recalled
This deviceK101961 Tigerpaw SystemLaax, Inc. · 2010
Descendant · cites it directly · 1 of its ownK111064 Tigerpaw System IILaax, Inc. · 2011 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK190884 TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery…Datascope Corp. · 2019

Class I recalls in this family

K111064 Tigerpaw System IIcites it directly · 2011

Most influential descendants

Showing 2 of 2 · See all

K111064Tigerpaw System IILaax, Inc. · 2011 · cites it directly1descendant
K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDatascope Corp. · 2019 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K842066	Peri-Guard Pericardial Patch	Genetic Laboratories, Inc.	1985	—
−3	K961811	Peri-Guard Pericardium	Bio-Vascular, Inc.	1996	—
−2	K983162	Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…	Bio-Vascular, Inc.	1998	2
−1	K040415	Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and…	Synovis Surgical Innovations	2004	1
0 (this device)	K101961	Tigerpaw System	Laax, Inc.	2010	—
+1	K111064	Tigerpaw System II	Laax, Inc.	2011	Class I
+2	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	1
2019	1	0

FIG. 1 — Lineage of K101961, 1985–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K032696	Auto Suture Endoscopic (& Open) TA Surgical Stapler, Auto Suture Endoscopic (& Open) Gia… Summary page 1 …in intended use and method of operation tO a combination of the following predicate devices: USGI Auto Suture TA & GIA Staplers K032696 Synovis Surgical Innovations, Peni-Strips Staple Line Reinforcement K(040415 Device Description: The TigerPaw®D System…	United States Surgical, A Division of Tyco Healthc	2003	—
*	K040415	Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and… Summary page 1 …ices: USGI Auto Suture TA & GIA Staplers K032696 Synovis Surgical Innovations, Peni-Strips Staple Line Reinforcement K(040415 Device Description: The TigerPaw®D System consists of an implantable Fastener and Delivery Tool designed for occlusion of the l…	Synovis Surgical Innovations	2004	1

Also cleared against K032696: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111064	Tigerpaw System II Class I	Laax, Inc.	2011	1

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 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
3 of the 11 ancestors have a recall of any class.
Of its descendants, K111064 (Laax, Inc., 2011) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K032696.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · GDW

3in 2025

2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007high 267 (2023) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GDW

3in 2025

2007high 22 (2009) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GDW

11,905in 2025

2007high 16,600 (2019) · low 2,380 (2008)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® System 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, 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/K101961 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101961: Tigerpaw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101961

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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