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510(k) K102566

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2011
Date Received
September 7, 2010
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.

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  • K150371 — Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DT (July 30, 2015)
  • K141586 — OWL CANNULAE (December 30, 2014)
  • 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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