510(k) Report

510(k) · Cleared

Cleared

Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device

K153611510(k) TraditionalCleared Jun 3, 2016169-day reviewClass II21 CFR 878.4493

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

Ethicon, LLC · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on Jun 3, 2016 as substantially equivalent to K082659 (Covidien Lp, Formerly Registered AS United States, 2008) and 2 other predicates after a 169-day review. Its family tree reaches back 2 generations to 1994.

Decided
Jun 3, 2016
Review
169 days
Class
Class II
Product code
GAM
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K934738 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor1995: 1 other ancestorK934738 · Autosuture Endoscopic Suturing Device · United States Surgical, A Division of Tyco Healthc · 1994 · recalledK082659 · Modified Endo Stich · Covidien Lp, Formerly Registered AS United States · 2008199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors K082659 · Modified Endo Stich · Covidien Lp, Formerly Registered AS United States · 2008K934738 · Autosuture Endoscopic Suturing Device · United States Surgical, A Division of Tyco Healthc · 1994 · recalled0
  1. Root · 2 generations backK934738 Autosuture Endoscopic Suturing DeviceUnited States Surgical, A Division of Tyco Healthc · 1994 · Recalled
  2. 1 generation backK082659 Modified Endo StichCovidien Lp, Formerly Registered AS United States · 2008
  3. This deviceK153611 Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture…Ethicon, LLC · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K934738Autosuture Endoscopic Suturing DeviceUnited States Surgical, A Division of Tyco Healthc19942
−1K082659Modified Endo StichCovidien Lp, Formerly Registered AS United States2008—
0 (this device)K153611Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges…Ethicon, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200210
FIG. 1 — Lineage of K153611, 1994–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 GAM? 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 GAM device

  1. #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 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? (3)

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
*K082659Modified Endo Stich
Summary page 4
…ice Class: II Panel: General & Plastic Surgery Product Code: GAT Predicate Devices: Modified Endo Stitch™ (K082659) Coated VICRYL™ (Polyglactin 910) Sterile Synthetic Absorbable Suture (…
Covidien Lp, Formerly Registered AS United States2008—
*K022269Coated Vicryl* (Polyglactin 910) Suture
Summary page 4
…Modified Endo Stitch™ (K082659) Coated VICRYL™ (Polyglactin 910) Sterile Synthetic Absorbable Suture (K022269) ETHIBOND EXCEL™ Polybutlylate Coated Polyester Sterile Synthetic Non-A…
ETHICON, Inc.20023
*K946173Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…
Summary page 4
…rbable Suture (K022269) ETHIBOND EXCEL™ Polybutlylate Coated Polyester Sterile Synthetic Non-Absorbable Suture (K946173) K153611, Page 2 of 3 Device Desc…
ETHICON, Inc.199510

Also cleared against K082659: 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 14.5 years on median.
  • 3 of the 4 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K082659.

How does its category compare?

All GAM devices

GAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · GAM

3in 2025

2007: 72008: 62009: 32010: 12011: 22012: 52013: 12014: 102015: 52016: 32017: 82018: 52019: 42020: 32021: 22022: 22023: 12024: 22025: 32026 (partial year): 4
2007high 10 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAM

29in 2025

2007: 50 days median2008: 174 days median2009: 10 days median2012: 31 days median2014: 121 days median2015: 209 days median2016: 169 days median2017: 134 days median2018: 98 days median2019: 90 days median2020: 140 days median2025: 29 days median2026 (partial year): 131 days median
2007high 209 (2015) · low 10 (2009)2026

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

Recalls per year · GAM

1in 2024

2007: 102008: 12009: 62010: 32011: 62016: 12017: 12019: 12020: 442022: 42024: 12026 (partial year): 2
2007high 44 (2020) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAM

8,970in 2025

2007: 2742008: 1942009: 2872010: 5872011: 6372012: 8682013: 8982014: 1,4102015: 9352016: 1,1122017: 1,4992018: 2,2292019: 3,5642020: 3,4152021: 4,5062022: 4,8142023: 5,0702024: 7,2262025: 8,970
2007high 8,970 (2025) · low 194 (2008)2025

MAUDE reports naming product code GAM, 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
200775010274
200861741194
20093106287
20101—3587
20112—6637
20125310868
20131—0898
20141012101,410
201552090935
2016316911,112
2017813411,499
201859802,229
201949013,564
20203140443,415
20212—04,506
20222—44,814
20231—05,070
20242—17,226
202532908,970
202641312—

What is it indicated for?

The PROXISURE™ Suturing Device, ETHIBOND™ Suture Cartridge, and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

The PROXISURE™ Suturing Device and ETHIBOND™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

The PROXISURE™ Suturing Device and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

Indications for use as stated in the FDA summary.

Also cleared against K082659

2 other devices cite the same predicate.

  • K201744Su2ura Approximation DeviceAnchora Medical, Ltd. · 2021
  • K090419Sils Stitch Endoscopic Suturing DeviceCovidien Lp, Formerly Registered AS United States · 2009

More from Ethicon, LLC

2 FDA decisions under this applicant name. See the company

  • K163645DERMABOND PRINEO Skin Closure SystemEthicon, LLC · 2017

Recent decisions in GAM

The GAM category page

  • K263073Fast Absorbing PGLARiverpoint Medical, LLC · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026
  • K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic · 2026
  • K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc. · 2026
  • K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue…ETHICON, Inc. · 2025

https://510kreport.com/device/K153611 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153611: Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153611

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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