Product code SIR— General, Plastic Surgery

OTTAVA Robotic Surgical System

Classification name: Integrated Operating Table-Electromechanical Surgical System
Device class: Class 2
Regulation: 21 CFR 878.4966
Advisory panel: General, Plastic Surgery
Total cleared: 1
First cleared: 2026-07-21
Most recent: 2026-07-21

FDA classification definition

“An integrated operating table-electromechanical surgical system is a software-controlled electromechanical platform, consisting of a surgical table with integrated robotic arms and table motion capability, that enables a qualified user to perform surgical techniques during minimally invasive and laparoscopic surgical procedures. The surgical table can be used for open surgical procedures independent of the robotic platform.”
— U.S. Food and Drug Administration, device classification record for product code SIR under 21 CFR 878.4966, via openFDA

Market context for product code SIR

FDA has cleared 1 device under product code SIR, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SIR

Auris Health, Inc., part of Johnson & Johnson MedTech1 clearance

Recent clearances under product code SIR

DEN250068 — OTTAVA Robotic Surgical SystemAuris Health, Inc., part of Johnson & Johnson MedTech·2026-07-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.