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SS Innovations submits response to FDA information request on SSi Mantra 510(k) filing
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SS Innovations submits response to FDA information request on SSi Mantra 510(k) filing
  • SS Innovations submitted its response to an FDA request for additional information on its 510(k) filing for the SSi Mantra.
  • The package includes final data from expanded human clinical and human factors validation work, plus a bridging study completed in August 2026.
  • FDA review of the response and the 510(k) is expected to conclude in Q1 2027 for an initial cholecystectomy indication.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. SS Innovations International Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202610130830PRIMZONEFULLFEED9844239) on October 13, 2026, and is solely responsible for the information contained therein.

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.
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