510(k) Report

510(k) · Cleared

Cleared

Subq IT! Bioabsorbable Skin Closure System

K131563510(k) TraditionalCleared Apr 9, 2014314-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

Opus Ksd, Inc. · GDW Staple, Implantable

Cleared on Apr 9, 2014 as substantially equivalent to K024117 (Incisive Surgical, Inc., 2003) and 4 other predicates after a 314-day review. Its family tree reaches back 4 generations to 1992.

Decided
Apr 9, 2014
Review
314 days
Class
Class II
Product code
GDW
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K915489 (1992). 10 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 1 other ancestor2009: 1 other ancestor2002: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor1992: 1 other ancestorK915489 · Auto Suture Absorable Subcuticular Closure Staple · United States Surgical, A Division of Tyco Healthc · 1992K024117 · Insorb Absorbable Staples, Model SP-B20 · Incisive Surgical, Inc. · 2003 · recalledK033602 · Insorb Absorbable Staple, Model SP-B20 · Incisive Surgical, Inc. · 2003 · recalledK061784 · Insorb Absorbable Staple, Model 1020 · Incisive Surgical, Inc. · 2006 · recalled199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors K061784 · Insorb Absorbable Staple, Model 1020 · Incisive Surgical, Inc. · 2006 · recalledK033602 · Insorb Absorbable Staple, Model SP-B20 · Incisive Surgical, Inc. · 2003 · recalledK024117 · Insorb Absorbable Staples, Model SP-B20 · Incisive Surgical, Inc. · 2003 · recalledK915489 · Auto Suture Absorable Subcuticular Closure Staple · United States Surgical, A Division of Tyco Healthc · 19920
  1. Root · 4 generations backK915489 Auto Suture Absorable Subcuticular Closure StapleUnited States Surgical, A Division of Tyco Healthc · 1992
  2. 3 generations backK024117 Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc. · 2003 · Recalled
  3. 2 generations backK033602 Insorb Absorbable Staple, Model SP-B20Incisive Surgical, Inc. · 2003 · Recalled
  4. 1 generation backK061784 Insorb Absorbable Staple, Model 1020Incisive Surgical, Inc. · 2006 · Recalled
  5. This deviceK131563 Subq IT! Bioabsorbable Skin Closure SystemOpus Ksd, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K915489Auto Suture Absorable Subcuticular Closure StapleUnited States Surgical, A Division of Tyco Healthc1992—
−3K024117Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc.20031
−2K033602Insorb Absorbable Staple, Model SP-B20Incisive Surgical, Inc.20031
−1K061784Insorb Absorbable Staple, Model 1020Incisive Surgical, Inc.20061
0 (this device)K131563Subq IT! Bioabsorbable Skin Closure SystemOpus Ksd, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199610
199810
200210
200910
201210
FIG. 1 — Lineage of K131563, 1992–2014Source: 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? (5)

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
*K024117Insorb Absorbable Staples, Model SP-B20
Summary page 7
…Skin staples and stapler Classification Name: Staple, implantable 3. PREDICATE DEVICES Incisive Surgical, INSORB™ Absorbable Staple (Multiple 510(k)’s e.g. K024117, K033602, K061784, K090159, K120373) 4. DEVICE DESCRIPTION The SubQ It!™ Bioabsorbable Skin Closure System comprise…
Incisive Surgical, Inc.20031
*K033602Insorb Absorbable Staple, Model SP-B20
Summary page 7
…nd stapler Classification Name: Staple, implantable 3. PREDICATE DEVICES Incisive Surgical, INSORB™ Absorbable Staple (Multiple 510(k)’s e.g. K024117, K033602, K061784, K090159, K120373) 4. DEVICE DESCRIPTION The SubQ It!™ Bioabsorbable Skin Closure System comprises bioabsorbabl…
Incisive Surgical, Inc.20031
*K061784Insorb Absorbable Staple, Model 1020
Summary page 7
…r Classification Name: Staple, implantable 3. PREDICATE DEVICES Incisive Surgical, INSORB™ Absorbable Staple (Multiple 510(k)’s e.g. K024117, K033602, K061784, K090159, K120373) 4. DEVICE DESCRIPTION The SubQ It!™ Bioabsorbable Skin Closure System comprises bioabsorbable fa…
Incisive Surgical, Inc.20061
*K090159Insorb Absorbable Staple, Model 1020, 1025, and Other Product Families
Summary page 7
…assification Name: Staple, implantable 3. PREDICATE DEVICES Incisive Surgical, INSORB™ Absorbable Staple (Multiple 510(k)’s e.g. K024117, K033602, K061784, K090159, K120373) 4. DEVICE DESCRIPTION The SubQ It!™ Bioabsorbable Skin Closure System comprises bioabsorbable fasteners m…
Incisive Surgical, Inc.20091
*K120373Insorb Absorbalbe Staple
Summary page 7
…ion Name: Staple, implantable 3. PREDICATE DEVICES Incisive Surgical, INSORB™ Absorbable Staple (Multiple 510(k)’s e.g. K024117, K033602, K061784, K090159, K120373) 4. DEVICE DESCRIPTION The SubQ It!™ Bioabsorbable Skin Closure System comprises bioabsorbable fasteners made of 82…
Incisive Surgical, Inc.20122

Also cleared against K024117: 2 other devices →

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 22 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
  • 8 of the 10 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K024117.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 SubQ It!™ Bioabsorbable Skin Closure System is intended for use in humans

for abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive

surgery for the subcuticular closure of skin where an absorbable tissue fastener

is desired for temporary tissue approximation.

Indications for use as stated in the FDA summary.

Also cleared against K024117

2 other devices cite the same predicate.

  • K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
  • K033602Insorb Absorbable Staple, Model SP-B20Incisive Surgical, Inc. · 20031 recall

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/K131563 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131563: Subq IT! Bioabsorbable Skin Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131563

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