510(k) · Cleared
ClearedTissueTak device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Via Surgical, Ltd. · GDW Staple, Implantable
Cleared on Jan 7, 2021 as substantially equivalent to K181668 (Via Surgical, Ltd., 2019) after an 83-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Jan 7, 2021
- Review
- 83 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K913469 (1991). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK913469 Endopath Disposable Endoscopic Multifeed StaplerETHICON, Inc. · 1991
- 7 generations backK032093 PariefixSofradim Production · 2003
- 6 generations backK060494 Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006
- 5 generations backK082396 Davol Absorbable Fastener System, Model (S) 0113080,0113081…C.R. Bard, Inc. · 2009
- 4 generations backK092483 Bard Permafix Fixation System, Model 0113012, 0113014, 0113016…C.R. Bard, Inc. · 2009
- 3 generations backK132698 Fastouch Fixation SystemVia Surgical, Ltd. · 2014
- 2 generations backK162252 FasTouch Fixation SystemVia Surgical, Ltd. · 2016
- 1 generation backK181668 FasTouch Absorbable Fixation SystemVia Surgical, Ltd. · 2019
- This deviceK203117 TissueTak deviceVia Surgical, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913469 | Endopath Disposable Endoscopic Multifeed Stapler | ETHICON, Inc. | 1991 | — |
| −7 | K032093 | Pariefix | Sofradim Production | 2003 | — |
| −6 | K060494 | Easytac Anchor. Easytac Delivery System | Medchannel, LLC | 2006 | — |
| −5 | K082396 | Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084… | C.R. Bard, Inc. | 2009 | — |
| −4 | K092483 | Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018 | C.R. Bard, Inc. | 2009 | — |
| −3 | K132698 | Fastouch Fixation System | Via Surgical, Ltd. | 2014 | — |
| −2 | K162252 | FasTouch Fixation System | Via Surgical, Ltd. | 2016 | — |
| −1 | K181668 | FasTouch Absorbable Fixation System | Via Surgical, Ltd. | 2019 | — |
| 0 (this device) | K203117 | TissueTak device | Via Surgical, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 GDW? 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 |
|---|---|---|---|
| * | K181668 | FasTouch Absorbable Fixation SystemSummary page 4…78.4750 Regulation Name- Implantable staple Regulatory class- class II Product Code- GDW Classification Panel- General & Plastic Surgery Predicate Device 510(k) Number- K181668 Name of Device- FasTouch Absorbable Fixation System Regulation Number- 21 CFR 878.4750 Regulation Name- Implantable staple Regula… | 2019 |
| † | K131637 | Rotation Medical Soft Tissue Staple (RMST Staple) | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 16 ancestors has a recall of any class.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 TissueTak device is intended for fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures such as hernia or rotator cuff repairs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203117: TissueTak device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203117
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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