GripTract-GI Endoscopic Tissue Manipulator
FDA 510(k) K231254 · Actuated Medical, Inc.
510(k) numberK231254
Submission
- Device name
- GripTract-GI Endoscopic Tissue Manipulator
- Applicant
- Actuated Medical, Inc.
Bellefonte, PA, US - Received
- May 1, 2023
- Decision date
- November 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDF – Colonoscope 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 colon or rectum 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).
Other 510(k)s with product code FDF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260503 | Triton 1 SystemFDF · Traditional | Neptune Medical, Inc. | 09/03/2026SE |
| K261015 | Solo Scope Colonoscope SystemFDF · Traditional | Gi View, Ltd. | 08/21/2026SE |
| K261587 | Insufflation Retention Device (IRD) (11173-325-101)FDF · Special | BPEndo, LLC | 07/02/2026SE |
| K260423 | Disposable Endoscopic Distal AttachmentsFDF · Traditional | Yangzhou Fartley Medical Instrument Technology… | 05/28/2026SE |
| K252457 | Disposable Distal End Tape HoodFDF · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 01/30/2026SE |
| K244029 | Robopera (ER-R-002); Robopera (ER-R-003)FDF · Traditional | Endorobotics Co., Ltd. | 09/24/2025SE |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…FDF · Traditional | Fujifilm Corporation | 05/23/2025SE |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…FDF · Traditional | Olympus Medical Systems Corporation | 05/15/2025SE |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF · Traditional | Pentax of America, Inc. | 01/03/2025SE |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsFDF · Traditional | Actuated Medical, Inc. | 10/04/2024SE |
More from Actuated Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251041 | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100FDS · Traditional | 10/31/2025SE |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsFDF · Traditional | 10/04/2024SE |
| 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 cleared by the FDA?
GripTract-GI Endoscopic Tissue Manipulator (K231254) received a 510(k) decision of Substantially Equivalent on November 3, 2023, 186 days after the submission was received.
What is the product code of K231254?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.