510(k) · Cleared
ClearedHernia Mesh Stabilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivices Co. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 1, 1998 after a 58-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Jul 1, 1998
- Review
- 58 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK981598 Hernia Mesh StabilizerMedivices Co. · 1998
- Descendant · cites it directly · 7 of its ownK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
- Descendant · 2 generations on · 6 of its ownK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 3 of its ownK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010 · cites it directly7descendants
- K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · 2 generations on6descendants
- K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · 3 generations on5descendants
- K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · 3 generations on4descendants
- K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981598 | Hernia Mesh Stabilizer | Medivices Co. | 1998 | — |
| +1 | K092726 | Mesh GPS - Large, Small, SM, SM Small | Surgical Structures, Ltd. | 2010 | — |
| +2 | K102766 | Composix L/P Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2010 | 2 |
| +3 | K110820 | Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System | C.R. Bard, Inc. | 2011 | — |
| +3 | K122436 | Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with… | C.R. Bard, Inc. | 2012 | 15 |
| +4 | K130968 | Ventralight ST Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2013 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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 |
|---|---|---|---|
| * | — | GraNee Needle System for Hernia Repair Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092726 | Mesh GPS - Large, Small, SM, SM Small | 2010 | 7 |
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, K092726 (Surgical Structures, Ltd., 2010) has gone furthest, with 7 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
Temporary mesh fixation to the inner surface of the abdominal wall to facilitate the permanent placement, by stapling, of the mesh when used in the standard fixation technique for Laparoscopic Hernia Repair.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981598 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981598: Hernia Mesh Stabilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981598
Report an extraction error
Are you the manufacturer?
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