FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)
K Number: K252926
·
Decision Mar 26, 2026
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
7
Applicant Total
1
Review Days
192
Basic Information
- Device Name
- Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)
- K Number
- K252926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Restore Robotics
- Date Received
- September 15, 2025
- Decision Date
- March 26, 2026
- Product Code
- QSM
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| QSM | System, Surgical, Computer Controlled Instrument, Remanufactured | FDA class 2 | Gastroenterology, Urology |
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