510(k) clearances

OTTAVA™ Robotic Surgical System

Auris Health, Inc., part of Johnson & Johnson MedTech · General, Plastic Surgery

DEN250068UnknownDirectSIR
Open FDA's page for this record
Third party flag
N
City
Santa Clara
Advisory committee description
General, Plastic Surgery
Address 1
5490 Great American Pkwy.
Product code
SIR
Zip code
95054
Applicant
Auris Health, Inc., part of Johnson & Johnson MedTech
Decision date
2026-07-21
Decision code
DENG
Country code
US
Device name
OTTAVA™ Robotic Surgical System
Advisory committee
SU
Contact
Anna (Inna) Libman
K number
DEN250068
State
CA
Date received
2025-12-18
Review advisory committee
SU
Postal code
95054
Decision description
Unknown
Clearance type
Direct
Harmonized identifiers (openFDA)
Device name
Integrated Operating Table-Electromechanical Surgical System
Medical specialty description
General, Plastic Surgery
Regulation number
878.4966
Device class
2
Registration number
3017425975, 8043903, 1221053, 1721983, 3015183635, 2183715, 1531174, 3010193531, 3002949731
FEI number
3014447948, 1221053, 3002993297, 1000064530, 3015183635, 2183715, 3002808088, 3010193531, 3002949731
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.