Regulatory filing

fda_510k (us_fda)

FDA 510(k) for Senhance surgical system. Class I recall (2023).

fda 510k · cleared · decided 2023-06-01

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REST API: /v1/filings/75b5d11c-d92b-4238-b8d8-92aa7453211c
Revision history: /regulatory-filings/asensus-senhance-fda-510k/history
Data documentation: /data
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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing date: 2023-01-01
Decision date: 2023-06-01
Verification posture: verified
Cap-flag notes: Class I recall 2023.

Applicant

Asensus Surgical

Covered models (1)

Senhance

Sources (1)

https://www.asensus.com/

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Identity

75b5d11c-d92b-4238-b8d8-92aa7453211c