FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Senhance Surgical System
K Number: K220889
·
Decision May 27, 2022
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
163
Applicant Total
5
Review Days
60
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Basic Information
- Device Name
- Senhance Surgical System
- K Number
- K220889
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Asensus Surgical, Inc.
- Date Received
- March 28, 2022
- Decision Date
- May 27, 2022
- Product Code
- NAY
- 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 |
|---|---|---|---|
| NAY | System, Surgical, Computer Controlled Instrument | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
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Other Clearances by Asensus Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233866 | Senhance Surgical System | Jul 19, 2024 | Substantially Equivalent |
| K223095 | Senhance Surgical System | Mar 16, 2023 | Substantially Equivalent |
| K212054 | Senhance Surgical System | Aug 30, 2021 | Substantially Equivalent |
| K211325 | Senhance Surgical System | Jul 27, 2021 | Substantially Equivalent |