510(k) · Cleared
ClearedG-Lix Tissue Grasper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usgi Medical · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Jul 31, 2006 as substantially equivalent to K930933 (ETHICON, Inc., 1993) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 1996. 2 later devices descend from it.
- Decided
- Jul 31, 2006
- Review
- 87 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K955051 (1996). 3 ancestors in all, the oldest K930933 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK955051 Olympus FG Series of Rat Tooth Grasping ForcepsOlympus America, Inc. · 1996
- 1 generation backK962474 Olympus FG Series of Rat Tooth Grasping Forceps (Urology)Olympus America, Inc. · 1996
- This deviceK061268 G-Lix Tissue GrasperUsgi Medical · 2006
- Descendant · cites it directly · 1 of its ownK080051 Virtual Ports Endoclear SystemVirtual Ports, Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK100346 Endoclear SystemVirtual Ports, Ltd. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955051 | Olympus FG Series of Rat Tooth Grasping Forceps | Olympus America, Inc. | 1996 | — |
| −1 | K962474 | Olympus FG Series of Rat Tooth Grasping Forceps (Urology) | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K061268 | G-Lix Tissue Grasper | Usgi Medical | 2006 | — |
| +1 | K080051 | Virtual Ports Endoclear System | Virtual Ports, Ltd. | 2008 | — |
| +2 | K100346 | Endoclear System | Virtual Ports, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K930933 | Endopath Endoscopic Surgical InstrumentsSummary page 1…IFICATION OF PREDICATE DEVICES EndoPATH Tissue Grasper Ethicon Endo-Surgery (K930933) FG Grasping Forcep, Olympus America… | 1993 |
| * | K962474 | Olympus FG Series of Rat Tooth Grasping Forceps (Urology)Summary page 1…(K930933) FG Grasping Forcep, Olympus America (K962474) CONFIDENTIAL 51I0(k) Prcrmarket Notification USGI Medical… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080051 | Virtual Ports Endoclear System | 2008 | 1 |
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 10 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K080051 (Virtual Ports, Ltd., 2008) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K930933.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The g-Lix Tissue Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization, especially for tissue which will be removed, such as the gall bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061268 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061268: G-Lix Tissue Grasper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061268
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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