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510(k) K170708

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2017
Date Received
March 8, 2017
Clearance Type
Special
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.

  • K150371 — Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DT (July 30, 2015)
  • 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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