FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Senhance Surgical System
K Number: K202166
·
Decision Mar 2, 2021
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
163
Applicant Total
15
Review Days
211
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Basic Information
- Device Name
- Senhance Surgical System
- K Number
- K202166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Transenterix, Inc.
- Date Received
- August 3, 2020
- Decision Date
- March 2, 2021
- 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
Other 510(k) clearances with the same product code (NAY), ordered by most recent decision date.
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da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
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da Vinci SP Surgical System (SP1098)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Transenterix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K200049 | Senhance Surgical System | Mar 9, 2020 | Substantially Equivalent |
| K192877 | Senhance Surgical System | Nov 22, 2019 | Substantially Equivalent |
| K191482 | Senhance Surgical System | Jul 11, 2019 | Substantially Equivalent |
| K182421 | Senhance Ultrasonic System | Jan 11, 2019 | Substantially Equivalent |
| K183098 | Senhance Surgical System | Dec 6, 2018 | Substantially Equivalent |
| K181517 | Senhance Surgical System | Oct 9, 2018 | Substantially Equivalent |
| K180163 | TransEnterix Senhance Surgical System | May 25, 2018 | Substantially Equivalent |
| K171120 | Senhance Surgical Robotic System | Oct 13, 2017 | Substantially Equivalent |
| K122299 | SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR | Oct 25, 2012 | Substantially Equivalent |
| K120403 | SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER | Apr 16, 2012 | Substantially Equivalent |