510(k) · Cleared
ClearedG-Prox Endoscopic Grasper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usgi Medical · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Dec 6, 2006 as substantially equivalent to K021019 (Genzyme Corp., 2002) and 4 other predicates after a 212-day review. Its family tree reaches back 4 generations to 1994. 5 later devices descend from it.
- Decided
- Dec 6, 2006
- Review
- 212 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K944415 (1994). 10 ancestors in all, the oldest K913469 (1991). 5 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK944415 Origin Tacker SystemOrigin Medsystems, Inc. · 1994
- 3 generations backK963999 Auto Suture* Modified Endoscopic Fascia Stapler** DeviceUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 2 generations backK013749 Endoanchor and OpenanchorEthicon Endo-Surgery, Inc. · 2002
- 1 generation backK023372 Non-Bioabsorbable StapleOnux Medical, Inc. · 2002
- This deviceK061276 G-Prox Endoscopic GrasperUsgi Medical · 2006
- Descendant · cites it directly · 1 of its ownK100251 G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical · 2010
- Descendant · cites it directly · 1 of its ownK093018 G-Prox Endoscopic Grasper, Model 205333Usgi Medical · 2009
- Descendant · 2 generations on · 0 of its ownK103688 G-Prox EZ Endoscopic GrasperUsgi Medical · 2011
- Descendant · cites it directly · 0 of its ownK102931 G-Cinch Suture GrasperUsgi Medical · 2010
- Descendant · cites it directly · 0 of its ownK102916 G-Cath Tissue Anchor Delivery CatheterUsgi Medical · 2010
Most influential descendants
Showing 5 of 5 · See all- K100251G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical · 2010 · cites it directly1descendant
- K093018G-Prox Endoscopic Grasper, Model 205333Usgi Medical · 2009 · cites it directly1descendant
- K103688G-Prox EZ Endoscopic GrasperUsgi Medical · 2011 · 2 generations on0descendants
- K102931G-Cinch Suture GrasperUsgi Medical · 2010 · cites it directly0descendants
- K102916G-Cath Tissue Anchor Delivery CatheterUsgi Medical · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944415 | Origin Tacker System | Origin Medsystems, Inc. | 1994 | — |
| −3 | K963999 | Auto Suture* Modified Endoscopic Fascia Stapler** Device | United States Surgical, A Division of Tyco Healthc | 1996 | 1 |
| −2 | K013749 | Endoanchor and Openanchor | Ethicon Endo-Surgery, Inc. | 2002 | — |
| −1 | K023372 | Non-Bioabsorbable Staple | Onux Medical, Inc. | 2002 | — |
| 0 (this device) | K061276 | G-Prox Endoscopic Grasper | Usgi Medical | 2006 | — |
| +1 | K100251 | G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333 | Usgi Medical | 2010 | — |
| +1 | K093018 | G-Prox Endoscopic Grasper, Model 205333 | Usgi Medical | 2009 | — |
| +2 | K103688 | G-Prox EZ Endoscopic Grasper | Usgi Medical | 2011 | — |
| +1 | K102931 | G-Cinch Suture Grasper | Usgi Medical | 2010 | — |
| +1 | K102916 | G-Cath Tissue Anchor Delivery Catheter | Usgi Medical | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester SutureSummary page 1…IDENTIFICATION OF PREDICATE DEVICES Polyester Non-absorbable Surgical Sutures Genzyme BioSurgery (K021019) Coil Fixation Device Onux Medical (K023372) EndoANCHOR Fixation Device… | 2002 |
| * | K023372 | Non-Bioabsorbable StapleSummary page 1…Sutures Genzyme BioSurgery (K021019) Coil Fixation Device Onux Medical (K023372) EndoANCHOR Fixation Device Ethicon Endo-Surgery… | 2002 |
| * | K013749 | Endoanchor and Openanchor | 2002 |
| * | K930933 | Endopath Endoscopic Surgical InstrumentsSummary page 2…(KO13749) EndoPATH Tissue Grasper Ethicon Endo-Surgery (K930933) FG Grasping Forcep Olympus America (K9… | 1993 |
| * | K962474 | Olympus FG Series of Rat Tooth Grasping Forceps (Urology)Summary page 2…(K930933) FG Grasping Forcep Olympus America (K962474) 4. DESCRIPTION OF THE DEVICE The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissu… | 1996 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K100251 (Usgi Medical, 2010) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K021019.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
The g-Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures
The g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061276 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061276: G-Prox Endoscopic Grasper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061276
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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