510(k) Report

510(k) · Cleared

Cleared

Autosuture Absorbable Tack and Applicator

K071920510(k) TraditionalCleared Sep 28, 200778-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

United States Surgical, A Division of Tyco Healthc · GDW Staple, Implantable

Cleared on Sep 28, 2007 as substantially equivalent to K071061 (Sorbx, LLC, 2007) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1995. 26 later devices descend from it.

Decided
Sep 28, 2007
Review
78 days
Class
Class II
Product code
GDW
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K951658 (1995). 3 ancestors in all. 26 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2009: 2 descendants cleared2013: 4 descendants cleared2011: 1 descendant cleared2023: 3 descendants cleared2015: 2 descendants cleared2012: 2 descendants cleared2010: 1 descendant cleared2014: 2 descendants cleared2016: 3 descendants cleared2017: 1 descendant cleared2022: 1 descendant cleared2019: 2 descendants cleared2021: 1 descendant cleared2026: 1 descendant clearedK951658 · Lactosorb Pop Rivet · Poly-Medics,Inc. · 1995K961585 · Surgical Dynamics Pop Rivet · United States Surgical, A Division of Tyco Healthc · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 7 descendants3 generations forward: 8 descendants4 generations forward: 7 descendants5 generations forward: 2 descendants K961585 · Surgical Dynamics Pop Rivet · United States Surgical, A Division of Tyco Healthc · 1996K951658 · Lactosorb Pop Rivet · Poly-Medics,Inc. · 19950+5
  1. Root · 2 generations backK951658 Lactosorb Pop RivetPoly-Medics,Inc. · 1995
  2. 1 generation backK961585 Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc · 1996
  3. This deviceK071920 Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  4. Descendant · cites it directly · 12 of its ownK091900 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States · 2009
  5. Descendant · cites it directly · 12 of its ownK090470 Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · Recalled
  6. Descendant · 2 generations on · 11 of its ownK093845 Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model…ETHICON, Inc. · 2010 · Recalled
  7. Descendant · 2 generations on · 4 of its ownK123109 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien · 2012
  8. Descendant · 3 generations on · 3 of its ownK132698 Fastouch Fixation SystemVia Surgical, Ltd. · 2014

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2009: 22010: 12011: 12012: 22013: 42014: 22015: 22016: 32017: 12019: 22021: 12022: 12023: 32026: 1
2009high 4 (2013) · low 0 (2018)2026

Most influential descendants

Showing 5 of 26 · See all
  • K091900Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States · 2009 · cites it directly12descendants
  • K090470Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · cites it directly12descendants
  • K093845Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25ETHICON, Inc. · 2010 · 2 generations on11descendants
  • K123109Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien · 2012 · 2 generations on4descendants
  • K132698Fastouch Fixation SystemVia Surgical, Ltd. · 2014 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K951658Lactosorb Pop RivetPoly-Medics,Inc.1995—
−1K961585Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc1996—
0 (this device)K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc2007—
+1K091900Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States2009—
+1K090470Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien20092
+2K093845Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25ETHICON, Inc.20101
+2K123109Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien2012—
+3K132698Fastouch Fixation SystemVia Surgical, Ltd.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201010
201110
201220
201340
201420
201520
201630
201710
201920
202110
202210
202330
202610
FIG. 1 — Lineage of K071920, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K071061Absorbatack and Applicator
Summary page 1
…UAL NAME: Absorbable Tack and Applicator CLASSIFICATION NAME: Implantable Staple PREDICATE DEVICE(S): AbsorbaTack TM and Applicator (K071061) E-Z TacTM (K961585) DEVICE DESCRIPTION: The Syneture TM Absorbable Tack and Applica…
Sorbx, LLC2007—
*K961585Surgical Dynamics Pop Rivet
Summary page 1
…r CLASSIFICATION NAME: Implantable Staple PREDICATE DEVICE(S): AbsorbaTack TM and Applicator (K071061) E-Z TacTM (K961585) DEVICE DESCRIPTION: The Syneture TM Absorbable Tack and Applicator are sterile sing…
United States Surgical, A Division of Tyco Healthc1996—

Also cleared against K071061: 1 other device →

What descends from it? (26)

See all 26

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091900Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States200912
K090470Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien200912

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 12 years and passes through 2 companies; a new generation was cleared every 11.2 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K091900 (Covidien Lp, Formerly Registered AS United States, 2009) has gone furthest, with 12 descendants of its own.
  • 1 other device also cites its predicate K071061.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GDW

3in 2025

2007: 82008: 72009: 132010: 102011: 112012: 92013: 132014: 152015: 82016: 112017: 132018: 72019: 122020: 102021: 92022: 72023: 42024: 22025: 32026 (partial year): 3
2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007: 56 days median2008: 57 days median2009: 27 days median2010: 39 days median2011: 49 days median2012: 45 days median2013: 49 days median2014: 63 days median2015: 111 days median2016: 96 days median2017: 103 days median2018: 90 days median2019: 205 days median2020: 88 days median2021: 233 days median2022: 89 days median2023: 267 days median2025: 111 days median2026 (partial year): 141 days median
2007high 267 (2023) · low 27 (2009)2026

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

Recalls per year · GDW

3in 2025

2007: 92009: 222010: 22011: 92012: 11, 1 Class I2013: 12015: 62016: 22017: 32018: 32019: 4, 4 Class I2020: 112023: 12025: 3
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

2007: 2,4012008: 2,3802009: 4,0142010: 3,7682011: 3,8262012: 3,7172013: 3,7772014: 4,7842015: 4,8992016: 5,1062017: 11,6432018: 14,9142019: 16,6002020: 12,3322021: 13,0152022: 13,6052023: 14,6232024: 13,2802025: 11,905
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200785692,401
200875702,380
20091327224,014
2010103923,768
2011114993,826
201294511 (1)3,717
2013134913,777
2014156304,784
2015811164,899
2016119625,106
201713103311,643
2018790314,914
2019122054 (4)16,600
202010881112,332
20219233013,015
2022789013,605
20234267114,623
20242—013,280
20253111311,905
202631410—

What is it indicated for?

The Syneture TM Absorbable Tack and Applicator are intended for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

Indications for use as stated in the FDA summary.

Also cleared against K071061

1 other device cites the same predicate.

  • K110728Imesh TackerEasylap, Ltd. · 2011

More from United States Surgical, A Division of…

218 FDA decisions under this applicant name. See the company

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006
  • K061095Auto Sutur Endo Gia StaplersUnited States Surgical, A Division of Tyco Healthc · 2006

Recent decisions in GDW

The GDW category page

  • K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic…Ezisurg Medical Co., Ltd. · 2026
  • K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler…Ethicon Endo-Surgery, LLC · 2026
  • K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads…Covidien (Part of Medtronic) · 2026
  • K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000…Ethicon Endo-Surgery, LLC · 2025
  • K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm…Ethicon Endo-Surgery, LLC · 2025

https://510kreport.com/device/K071920 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071920: Autosuture Absorbable Tack and Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071920

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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