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FDA De NovoFDA De Novo. Stage 4 of 4 (Authorized)

FDA Grants De Novo to J&J's OTTAVA Table-Integrated Surgical Robot

The authorization creates a new Class II device type for operating tables with built-in robotic arms, authorized for upper abdominal laparoscopic surgery.

By News DeskJuly 22, 20262 min read
A white operating table with robotic arms attached to its sides, flanked by a surgeon console and an equipment tower in a bright white room
The OTTAVA Robotic Surgical System, with robotic arms mounted on the operating table, in an image released by Johnson & Johnson. Photo: Johnson & Johnson · Company press image published with the announcement
FDA De Novonew device type · DEN250068FDA De Novo. Stage 4 of 4 (Authorized)

The FDA granted this device through the De Novo pathway, used for new low-to-moderate-risk device types with no existing equivalent.

Key points

  • The FDA granted De Novo request DEN250068 for the OTTAVA Robotic Surgical System on July 21, 2026, creating the device type 'integrated operating table-electromechanical surgical system.'
  • The system is indicated for adult upper abdominal general laparoscopic procedures; J&J lists ten procedures including gastric bypass, cholecystectomy and hiatal hernia repair.
  • J&J plans a launch with select US customers; a US trial in inguinal hernia procedures is ongoing.

The US Food and Drug Administration has granted De Novo authorization to Johnson & Johnson's OTTAVA Robotic Surgical System, a soft-tissue surgical robot whose four arms are built into the operating table, the company announced on July 22.

J&J said the system is authorized for multiple general surgery procedures, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair. The company called OTTAVA the world's first table-integrated soft tissue robotic system.

A new device type

The FDA's decision letter, dated July 21 and addressed to Auris Health, Inc., part of Johnson & Johnson MedTech, classifies the system in Class II under a new regulation, 21 CFR 878.4966, with the generic name "integrated operating table-electromechanical surgical system." The agency defines that type as a software-controlled platform consisting of a surgical table with integrated robotic arms and table motion capability. The letter notes that the table can be used for open surgery independently of the robotic platform.

According to the letter, the system is intended to assist in the control of endoscopic instruments for grasping, cutting, dissection, ligation, electrosurgery and suturing, and to let surgical staff reposition the patient by adjusting the table without undocking, during upper abdominal general laparoscopic procedures. It is indicated for adults and for use by trained physicians in an operating room. The FDA's De Novo database lists the request as DEN250068, received December 18, 2025, with product code SIR.

What J&J says the system does

The company said the table-integrated arms occupy 30 to 50% less space than boom- and cart-mounted systems, based on its evaluation of systems available as of September 2025. Software coordinates the arms to move into pre-defined procedural poses for setup and breakdown, and a feature J&J calls twin motion moves the table and arms together to reposition the patient. The instrument set includes a two-in-one needle driver that the company said is designed to reduce unintended suture cutting. OTTAVA connects to J&J's Polyphonic digital platform for training, media and surgical data.

"We are pioneering a new category of surgical robotics with OTTAVA," said Tim Schmid, executive vice president and worldwide chairman of MedTech at J&J.

J&J said it will launch OTTAVA commercially with select US customers, focusing on early customer success while working toward additional indications and other regulatory jurisdictions. A US clinical trial of the system in inguinal hernia procedures is ongoing, the company said. It did not disclose pricing. J&J scheduled an investor conference call on August 3 to discuss the announcement.

Sources

  1. Johnson & Johnson Receives FDA Market Authorization in the U.S. for its OTTAVA Robotic Surgical System, Johnson & Johnson, July 22, 2026
  2. De Novo decision letter DEN250068: OTTAVA Robotic Surgical System, US Food and Drug Administration, July 21, 2026
  3. De Novo database entry DEN250068: OTTAVA Robotic Surgical System (page as updated 2026-10-26; facts cited were in the 2026-07-21 version), US Food and Drug Administration, July 21, 2026