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OTTAVA™ Robotic Surgical System

by Auris Health, Inc., part of Johnson & Johnson MedTech

De Novo DEN250068

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN250068 Date21 Jul 2026DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
SIR
Device Class
Class II
Regulation
21 CFR Part 878.4966
Advisory Committee
General, Plastic Surgery
FDA Decision
DENG De Novo granted