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510(k) K150371

Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH by Diros Technology, Inc. — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2015
Date Received
February 13, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Radiofrequency Lesion
Device Class
Class II
Regulation Number
882.4725
Review Panel
NE
Submission Type

Other clearances by Diros Technology, Inc.

  • K170708 — OWL RF INSULATED CANNULAE (June 27, 2017)
  • K141586 — OWL CANNULAE (December 30, 2014)
  • K102566 — OWL CANNULAE (June 3, 2011)
  • K110593 — OWL RF PROBES (May 5, 2011)
  • K093185 — OWL UNIVERSAL RF SYSTEM URF-3AP (ML) (January 22, 2010)
  • K062758 — OWL URF-3AP (September 27, 2006)
  • K021869 — OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP (July 1, 2002)

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