510(k) Report

510(k) · Cleared

Cleared

Absorbatack and Applicator

K071061510(k) TraditionalCleared May 16, 200730-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

Sorbx, LLC · GDW Staple, Implantable

Cleared on May 16, 2007 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 27 later devices descend from it.

Decided
May 16, 2007
Review
30 days
Class
Class II
Product code
GDW
Recalls
None
Predicates
0

27 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2007: 1 descendant cleared2009: 2 descendants cleared2016: 3 descendants cleared2013: 4 descendants cleared2023: 3 descendants cleared2015: 2 descendants cleared2012: 2 descendants cleared2010: 1 descendant cleared2014: 2 descendants cleared2017: 1 descendant cleared2022: 1 descendant cleared2019: 2 descendants cleared2021: 1 descendant cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK071061 Absorbatack and ApplicatorSorbx, LLC · 2007
  2. Descendant · cites it directly · 26 of its ownK071920 Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  3. Descendant · 2 generations on · 12 of its ownK091900 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States · 2009
  4. Descendant · 2 generations on · 12 of its ownK090470 Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · Recalled
  5. Descendant · 3 generations on · 11 of its ownK093845 Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model…ETHICON, Inc. · 2010 · Recalled
  6. Descendant · 3 generations on · 4 of its ownK123109 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien · 2012

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2007: 12009: 22010: 12011: 12012: 22013: 42014: 22015: 22016: 32017: 12019: 22021: 12022: 12023: 32026: 1
2007high 4 (2013) · low 0 (2008)2026

Most influential descendants

Showing 5 of 27 · See all
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007 · cites it directly26descendants
  • K091900Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States · 2009 · 2 generations on12descendants
  • K090470Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · 2 generations on12descendants
  • K093845Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25ETHICON, Inc. · 2010 · 3 generations on11descendants
  • K123109Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien · 2012 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K071061Absorbatack and ApplicatorSorbx, LLC2007—
+1K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc2007—
+2K091900Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien Lp, Formerly Registered AS United States2009—
+2K090470Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien20092
+3K093845Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25ETHICON, Inc.20101
+3K123109Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200920
201010
201110
201220
201340
201420
201520
201630
201710
201920
202110
202210
202330
202610
FIG. 1 — Lineage of K071061, 2007–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc200726
K110728Imesh TackerEasylap, Ltd.20111

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?

  • Of its descendants, K071920 (United States Surgical, A Division of Tyco Healthc, 2007) has gone furthest, with 26 descendants of its own.

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 AbsorbaTackTM and Applicator are indicated 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 510(k) statement.

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/K071061 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071061: Absorbatack 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/K071061

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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