510(k) Report

510(k) · Cleared

Cleared

Hepatostat Set, Model 760X

K061796510(k) TraditionalCleared Nov 2, 2006129-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

Vygon Corp. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on Nov 2, 2006 as substantially equivalent to K924223 (Mar-Med Co., 1993) and 3 other predicates after a 129-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.

Decided
Nov 2, 2006
Review
129 days
Class
Class II
Product code
GAM
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K944110 (1995). 8 ancestors in all, the oldest K924223 (1993). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2001: 2 other ancestors1993: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor2008: 1 descendant clearedK944110 · Vicryl Rapide Suture · ETHICON, Inc. · 1995 · recalledK031286 · Safil and Safil Quick Synthetic Absorbable Surgical Suture · Aesculap, Inc. · 2003 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant K031286 · Safil and Safil Quick Synthetic Absorbable Surgical Suture · Aesculap, Inc. · 2003 · recalledK944110 · Vicryl Rapide Suture · ETHICON, Inc. · 1995 · recalled0
  1. Root · 2 generations backK944110 Vicryl Rapide SutureETHICON, Inc. · 1995 · Recalled
  2. 1 generation backK031286 Safil and Safil Quick Synthetic Absorbable Surgical SutureAesculap, Inc. · 2003 · Recalled
  3. This deviceK061796 Hepatostat Set, Model 760XVygon Corp. · 2006
  4. Descendant · cites it directly · 0 of its ownK073493 Hepatostat SetVygon Corp. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K073493Hepatostat SetVygon Corp. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K944110Vicryl Rapide SutureETHICON, Inc.19952
−1K031286Safil and Safil Quick Synthetic Absorbable Surgical SutureAesculap, Inc.20031
0 (this device)K061796Hepatostat Set, Model 760XVygon Corp.2006—
+1K073493Hepatostat SetVygon Corp.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199610
199810
200120
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K061796, 1995–2008Source: 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 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? (4)

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
*K924223Mar-Med Liver Strap
Summary page 1
…M Classification Name: Synthetic Absorbable Surgical Suture & Surgical Clamp Classification: Class I1 Predicate Device Name: Mar-Med Liver Strap (K924223) Safil Synthetic Absorbable Surgical Suture (K031286) MonoSyn Synthetic Abs…
Mar-Med Co.1993—
*K031286Safil and Safil Quick Synthetic Absorbable Surgical Suture
Summary page 1
…amp Classification: Class I1 Predicate Device Name: Mar-Med Liver Strap (K924223) Safil Synthetic Absorbable Surgical Suture (K031286) MonoSyn Synthetic Absorbable Surgical Suture (K011375) Vicryl Synthetic Ab…
Aesculap, Inc.20031
*K011375Aesculap, Inc., Monosyn Synthetic Absorbable Surgical Suture
Summary page 1
…Strap (K924223) Safil Synthetic Absorbable Surgical Suture (K031286) MonoSyn Synthetic Absorbable Surgical Suture (K011375) Vicryl Synthetic Absorbable Surgical Suture (K033746) Device Description: The Hepatostat Set i…
Aesculap, Inc.2001—
*K033746Modified Coated Vicryl* Rapide (Polyglactin 910) Suture
Summary page 1
…uture (K031286) MonoSyn Synthetic Absorbable Surgical Suture (K011375) Vicryl Synthetic Absorbable Surgical Suture (K033746) Device Description: The Hepatostat Set is an absorbable compression device which was developed…
ETHICON, Inc.20033

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073493Hepatostat SetVygon Corp.20080

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 11 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
  • 4 of the 8 ancestors have a recall of any class.
  • Of its descendants, K073493 (Vygon Corp., 2008) has gone furthest, with 0 descendants of its own.

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.

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?

Hepatostat Set is a compression system acting as a tourniquet on the

hepatic tissue. It is intended to reduce the risk of bleeding and to

achieve hemostasis in hepatic resections (from large to small superficial

hepatectomy). It can also be used for traumatic liver injuries.

Indications for use as stated in the FDA summary.

More from Vygon Corp.

48 FDA decisions under this applicant name. See the company

  • K121105Nutrisafe 2 Feeding TubeVygon Corp. · 2012
  • K100163Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXVygon Corp. · 2011
  • K073493Hepatostat SetVygon Corp. · 2008
  • K070705Modification to: Latex-Free Bionector, Model# 896.019, 896.039Vygon Corp. · 200713 recalls
  • K061250Multicath ExpertVygon Corp. · 2006

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/K061796 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061796: Hepatostat Set, Model 760X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061796

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