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Sonablate 450

by Sonacare Medical, LLC

De Novo DEN150011

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN150011 Date9 Oct 2015DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
PLP
Device Class
Class II
Regulation
21 CFR Part 876.4340
Advisory Committee
Gastroenterology, Urology
FDA Decision
DENG De Novo granted

Other devices from Sonacare Medical, LLC

  • Sonablate

    Class II