510(k) · Cleared
ClearedGripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Actuated Medical, Inc. · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Oct 31, 2025 as substantially equivalent to K242325 (Actuated Medical, Inc., 2024) after a 211-day review. Its family tree reaches back 2 generations to 2023.
- Decided
- Oct 31, 2025
- Review
- 211 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K231254 (2023). No later device cites it as a predicate yet.
- Root · 2 generations backK231254 GripTract-GI Endoscopic Tissue ManipulatorActuated Medical, Inc. · 2023
- 1 generation backK242325 GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsActuated Medical, Inc. · 2024
- This deviceK251041 GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100Actuated Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K231254 | GripTract-GI Endoscopic Tissue Manipulator | Actuated Medical, Inc. | 2023 | — |
| −1 | K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | Actuated Medical, Inc. | 2024 | — |
| 0 (this device) | K251041 | GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | Actuated Medical, Inc. | 2025 | — |
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 FDS? 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 FDS device
- #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.5 · 12 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 |
|---|---|---|---|
| * | K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsSummary page 5…e: FDS Predicate Device Trade Name GripTract-GI™ Endoscopic Tissue Manipulator Lower GI Models 510(k) Number K242325 Submitter Actuated Medical, Inc.… | 2024 |
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 2 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FDS devicesFDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FDS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDS
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDS
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDS
18,905in 2025
MAUDE reports naming product code FDS, 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 | 2 | — | 0 | 27 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 1 | — | 0 | 45 |
| 2011 | 1 | — | 0 | 36 |
| 2012 | 3 | 181 | 0 | 35 |
| 2013 | 2 | — | 1 | 8 |
| 2014 | 2 | — | 0 | 23 |
| 2015 | 2 | — | 0 | 29 |
| 2016 | 1 | — | 1 | 108 |
| 2017 | 1 | — | 0 | 178 |
| 2018 | 6 | 167 | 0 | 304 |
| 2019 | 5 | 175 | 0 | 1,376 |
| 2020 | 2 | — | 2 | 601 |
| 2021 | 5 | 78 | 0 | 1,755 |
| 2022 | 2 | — | 0 | 6,216 |
| 2023 | 3 | 133 | 0 | 9,874 |
| 2024 | 5 | 220 | 2 | 9,258 |
| 2025 | 8 | 211 | 0 | 18,905 |
| 2026 | 7 | 164 | 0 | — |
What is it indicated for?
The GripTract-GI Endoscopic Tissue Manipulator (GripTract) Upper GI Model is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.
GripTract Upper GI Model is indicated for use in the upper gastrointestinal tract with any standard endoscope as follows:
Endoscope Distal Tip Outer Diameter (mm): 9.8- 10.5
Endoscope Working Length (cm): 103 - 110
GripTract Model#: GT-GS100
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251041: GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251041
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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