FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
K Number: K251041
·
Decision Oct 31, 2025
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
74
Applicant Total
10
Review Days
211
Basic Information
- Device Name
- GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
- K Number
- K251041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Actuated Medical, Inc.
- Date Received
- April 3, 2025
- Decision Date
- October 31, 2025
- Product Code
- FDS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FDS | Gastroscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Actuated Medical, Inc.
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|---|---|---|---|
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| K220890 | IO Needle Safety Sheath | Oct 31, 2022 | Substantially Equivalent |
| K200646 | TubeClear System | Dec 4, 2020 | Substantially Equivalent |
| K172556 | TubeClear System | Jun 29, 2018 | Substantially Equivalent |
| K163092 | TubeClear Control Box and Clearing Stem | Nov 30, 2016 | Substantially Equivalent |
| K131052 | TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) | Aug 16, 2013 | Substantially Equivalent |
| K123659 | TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) | Dec 20, 2012 | Substantially Equivalent |
| K121571 | TUBECLEAR | Jun 13, 2012 | Substantially Equivalent |