De Novo · Granted
GrantedOTTAVA™ Robotic Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auris Health, Inc., part of Johnson & Johnson MedTech · SIR Integrated Operating Table-Electromechanical Surgical System
Granted on Jul 21, 2026 as a new device type through De Novo after a 215-day review.
- Decided
- Jul 21, 2026
- Review
- 215 days
- Class
- Class II
- Product code
- SIR
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SIR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SIR devicesSIR Integrated Operating Table-Electromechanical Surgical System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SIR
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SIR
Too few SIR 510(k)s in any year since 2007 to give a median.
Recalls per year · SIR
No recall names SIR since 2007.
Adverse event reports per year · SIR
No MAUDE report names SIR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OTTAVA™ Robotic Surgical System is intended to assist in the accurate control of endoscopic Instruments, Endoscopes, and Accessories for visualization and manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, suturing, and to allow the surgical staff to reposition the patient by adjusting the Table without undocking during upper abdominal general laparoscopic surgical procedures in accordance with the representative, specific procedures set forth in the Instructions for Use. The System is indicated for adult use. It is intended to be used by trained physicians in an operating room environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250068 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250068: OTTAVA™ Robotic Surgical System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250068
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026