510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250068Unknown

OTTAVA™ Robotic Surgical System

Auris Health, Inc., part of Johnson & Johnson MedTech, Santa Clara CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN250068 is the FDA 510(k) clearance record for OTTAVA™ Robotic Surgical System, a class II device, cleared for Auris Health, Inc., part of Johnson & Johnson MedTech on under FDA product code SIR (Integrated Operating Table-Electromechanical Surgical System). FDA's definition for product code SIR reads: "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...". FDA records list one 510(k) clearance for Auris Health, Inc., part of Johnson & Johnson MedTech. As of , FDA records show no recalls naming DEN250068.

Clearance record

Decision date
Received
(215 days to decision)
Product code
SIR Integrated Operating Table-Electromechanical Surgical System
Regulation
21 CFR 878.4966
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Auris Health, Inc., part of Johnson & Johnson MedTech 5490 Great American Pkwy., Santa Clara CA
Third party review
No

Clearances, product code SIR

Trailing 12 months
1 clearance under product code SIR in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SIR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260