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510(k) K141586

OWL CANNULAE by Diros Technology, Inc. — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2014
Date Received
June 13, 2014
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)
  • K150371 — Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DT (July 30, 2015)
  • 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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