Ottava

1. 5

   Regulator-cleared or mass marketThis robot

   A regulator has cleared it where approval applies: FDA clearance or approval for a medical robot, a permit to run with no one aboard for a self-driving vehicle, or an FAA approval for routine drone flights. Or: Widely sold: sales in the hundreds of thousands, or a product category you can buy in ordinary shops.

   Placed by: The FDA granted Ottava De Novo authorization for 10 general surgery operations in the upper belly, including gastric bypass, gallbladder removal and hiatal hernia repair (22 July 2026).

2. 4

   Paying customers

   Delivered to customers who pay for it, beyond a trial, or a paid service the public can use.

3. 3

   Pilot

   Working with a named customer in a real setting, as a trial.

4. 2

   Pre-orders

   Orders, reservations or deposits taken, with nothing delivered yet.

5. 1

   Demo only

   Shown in videos, staged events or a factory, with no units working for customers.

What we couldn't confirm. We did not find the DEN number of the July 2026 De Novo in a source we opened. The hint's njbiz report was not opened; the date and procedures were confirmed from J&J's own release. J&J first said trials would start in the second half of 2022.