Regulatory filing
K171120 (us_fda)
Foundational US FDA 510(k) clearance of the Senhance Surgical Robotic System; filed by TransEnterix, Inc. (later renamed Asensus Surgical). (The earlier De Novo DEN160056 could not be corroborated to a primary record - honest-absence.)
fda 510k · cleared · decided 2017-10-13
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- Markdown mirror: /regulatory-filings/fda-510k-senhance-2017.md
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- Revision history: /regulatory-filings/fda-510k-senhance-2017/history
- Data documentation: /data
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Key facts
- Jurisdiction
- us_fda
- Filing type
- fda 510k
- Status
- cleared
- Filing number
- K171120
- Filing date
- 2017-04-14
- Decision date
- 2017-10-13
- Verification posture
- verified
Applicant
Covered models (1)
Sources (1)
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Identity
ef5b58b5-1e8f-40cf-9bfe-7aa53e51a2de