FDA grants 510(k) clearance to Momentis Surgical Anovo system for multiport surgery, first platform supporting all three surgical access approaches
[REGULATORY ACTION]Jul 23, 2026 · Momentis Surgical · ANOVO · Fort Myers, Florida, USA
Failure Mode
REGULATORY ACTION
Event Date
Jul 23, 2026
Primary Entity
Momentis Surgical
Robotic Platform
ANOVO
Jurisdiction / Location
Fort Myers, Florida, USA
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
The U.S. FDA granted 510(k) clearance for the multiport configuration of Momentis Surgical's Anovo Surgical System on July 23, 2026. The clearance makes Anovo the first robotic surgical platform capable of supporting natural orifice, single-port, and multiport procedures on a single system, expanding the platform beyond its previously cleared indications.
System & Fleet Architecture
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.prnewswire.com/news-releases/fda-clears-momentis-surgicals-anovo-system-for-multiport-surgery-making-it-the-first-robotic-platform-to-support-three-surgical-approaches-302833131.html
https://www.prnewswire.com/news-releases/fda-clears-momentis-surgicals-anovo-system-for-multiport-surgery-making-it-the-first-robotic-platform-to-support-three-surgical-approaches-302833131.html
- Inspect Filing
https://www.massdevice.com/fda-clears-momentis-multi-port-robot/
https://www.massdevice.com/fda-clears-momentis-multi-port-robot/
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Details
Incident Context & FAQ
What happened in FDA grants 510(k) clearance to Momentis Surgical Anovo system for multiport surgery, first platform supporting all three surgical access approaches?
The U.S. FDA granted 510(k) clearance for the multiport configuration of Momentis Surgical's Anovo Surgical System on July 23, 2026. The clearance makes Anovo the first robotic surgical platform capable of supporting natural orifice, single-port, and multiport procedures on a single system, expanding the platform beyond its previously cleared indications.
When did this incident occur?
The incident is recorded as occurring on July 23, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA grants 510(k) clearance to Momentis Surgical Anovo system for multiport surgery, first platform supporting all three surgical access approaches?
ANOVO by Momentis Surgical is the recorded robot involved in this incident at Fort Myers, Florida, USA.
Has anyone responded to FDA grants 510(k) clearance to Momentis Surgical Anovo system for multiport surgery, first platform supporting all three surgical access approaches?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA grants 510(k) clearance to Momentis Surgical Anovo system for multiport surgery, first platform supporting all three surgical access approaches?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.