510(k) · Cleared
ClearedG-Cinch Suture Grasper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usgi Medical · OCW Endoscopic Tissue Approximation Device
Cleared on Dec 30, 2010 as substantially equivalent to K061276 (Usgi Medical, 2006) and 1 other predicate after an 87-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Dec 30, 2010
- Review
- 87 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K944415 (1994). 12 ancestors in all, the oldest K913469 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK944415 Origin Tacker SystemOrigin Medsystems, Inc. · 1994
- 4 generations backK963999 Auto Suture* Modified Endoscopic Fascia Stapler** DeviceUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 3 generations backK013749 Endoanchor and OpenanchorEthicon Endo-Surgery, Inc. · 2002
- 2 generations backK023372 Non-Bioabsorbable StapleOnux Medical, Inc. · 2002
- 1 generation backK061276 G-Prox Endoscopic GrasperUsgi Medical · 2006
- This deviceK102931 G-Cinch Suture GrasperUsgi Medical · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944415 | Origin Tacker System | Origin Medsystems, Inc. | 1994 | — |
| −4 | K963999 | Auto Suture* Modified Endoscopic Fascia Stapler** Device | United States Surgical, A Division of Tyco Healthc | 1996 | 1 |
| −3 | K013749 | Endoanchor and Openanchor | Ethicon Endo-Surgery, Inc. | 2002 | — |
| −2 | K023372 | Non-Bioabsorbable Staple | Onux Medical, Inc. | 2002 | — |
| −1 | K061276 | G-Prox Endoscopic Grasper | Usgi Medical | 2006 | — |
| 0 (this device) | K102931 | G-Cinch Suture Grasper | 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 | 3 | 0 |
| 2002 | 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 OCW? 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 OCW device
- #1 K252400 Endomina EZFuse systemscore 12.0 · 5 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 |
|---|---|---|---|
| * | K061276 | G-Prox Endoscopic GrasperSummary page 1…. IDENTIFICATION OF PREDICATE DEVICES g-Cath Tissue Anchor Delivery Catheter USGI Medical (K061 276) Endosuture System Endo-Holder Knot Pusher Ethicon (K963… | 2006 |
| * | K963329 | Ethicon Endosuture SystemSummary page 1…(K061 276) Endosuture System Endo-Holder Knot Pusher Ethicon (K963329) jfloCi3 i 4. DESCRIP… | 1996 |
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 16 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 3 other devices also cite its predicate K061276.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The g-Cinch is intended for use with the g-Cath Tissue Anchor Delivery
Catheter for suture grasping and cinching of g-Cath Tissue Anchors
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102931: G-Cinch Suture Grasper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102931
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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