GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
FDA 510(k) K251041 · Actuated Medical, Inc.
510(k) numberK251041
Submission
- Device name
- GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
- Applicant
- Actuated Medical, Inc.
Bellefonte, PA, US - Received
- April 3, 2025
- Decision date
- October 31, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDS – Gastroscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000)FDS · Traditional | Intuitive Surgical, Inc. | 08/07/2026SE |
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| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS · Traditional | Fujifilm Corporation | 02/17/2026SE |
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| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…FDS · Traditional | Pentax of America, Inc. | 12/16/2025SE |
| K251708 | EvoEndo Single-Use Endoscopy SystemFDS · Traditional | EvoEndo, Inc. | 10/10/2025SE |
| K243388 | Disposable Distal CapFDS · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 06/27/2025SE |
| K250900 | EvoEndo Single-Use Endoscopy SystemFDS · Traditional | EvoEndo, Inc. | 06/16/2025SE |
More from EvoEndo, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsFDF · Traditional | 10/04/2024SE |
| K231254 | GripTract-GI Endoscopic Tissue ManipulatorFDF · Traditional | 11/03/2023SE |
| K220890 | IO Needle Safety SheathFMI · Traditional | 10/31/2022SE |
| K200646 | TubeClear SystemKNT · Traditional | 12/04/2020SE |
| K172556 | TubeClear SystemKNT · Traditional | 06/29/2018SE |
| K163092 | TubeClear Control Box and Clearing StemKNT · Traditional | 11/30/2016SE |
| K131052 | Tubeclear Model 101 (with New Clearing Stem Ne and G Models)KNT · Traditional | 08/16/2013SE |
| K123659 | Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of Tubeclear)KNT · Special | 12/20/2012SE |
| K121571 | TubeclearKNT · Traditional | 06/13/2012SE |
Questions and answers
When was GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 cleared by the FDA?
GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (K251041) received a 510(k) decision of Substantially Equivalent on October 31, 2025, 211 days after the submission was received.
What is the product code of K251041?
The FDA product code is FDS – Gastroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.