510(k) · Cleared
ClearedHepatostat Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon Corp. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on May 6, 2008 as substantially equivalent to K061796 (Vygon Corp., 2006) after a 146-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 6, 2008
- Review
- 146 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944110 (1995). 9 ancestors in all, the oldest K924223 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK944110 Vicryl Rapide SutureETHICON, Inc. · 1995 · Recalled
- 2 generations backK031286 Safil and Safil Quick Synthetic Absorbable Surgical SutureAesculap, Inc. · 2003 · Recalled
- 1 generation backK061796 Hepatostat Set, Model 760XVygon Corp. · 2006
- This deviceK073493 Hepatostat SetVygon Corp. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944110 | Vicryl Rapide Suture | ETHICON, Inc. | 1995 | 2 |
| −2 | K031286 | Safil and Safil Quick Synthetic Absorbable Surgical Suture | Aesculap, Inc. | 2003 | 1 |
| −1 | K061796 | Hepatostat Set, Model 760X | Vygon Corp. | 2006 | — |
| 0 (this device) | K073493 | Hepatostat Set | Vygon Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
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 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061796 | Hepatostat Set, Model 760XSummary page 1…GAM & GDJ Classification Name: Synthetic Absorbable Surgical Suture & Surgical Clamp Classification: Class II Predicate Device Name: Hepatostat (K061796) Device Description: The I lepatostat Set® is an absorbable compression device which allows to p… | 2006 |
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 13 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 4 of the 9 ancestors have a recall of any class.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
Hepatostat Set is an absorbable compression system acting as a tourniquet on the hepatic, splenic and nephric tissue. It is used to achieve hemostasis in hepatic, splenic, and nephric resections. It can also be used for traumatic liver, kidney and spleen injuries. It is designed to provide compressive hemostasis to the wound site, and resorb naturally over time after hemostasis has been achieved.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073493 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073493: Hepatostat Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073493
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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