Home / 510(k) Clearances / K062758

510(k) K062758

OWL URF-3AP by Diros Technology, Inc. — Product Code GXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2006
Date Received
September 15, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
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)
  • 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)
  • K021869 — OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP (July 1, 2002)

Other clearances for product code GXD

  • K251247 — GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (August 7, 2025)
  • K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADV (August 14, 2024)
  • K232632 — Racz Neurostat RF Generator (May 24, 2024)
  • K231675 — OneRF Ablation System (December 6, 2023)
  • K220122 — APEX 6 (March 15, 2023)
  • K203293 — Abbott Medical Grounding Pad, model RF-DGP-IS (January 21, 2022)
  • K201610 — IonicRF Generator (October 21, 2020)
  • K192491 — Coolief Radiofrequency Generator (CRG) System (February 21, 2020)
  • K181864 — Polaris RF Ablation System (January 2, 2019)
  • K171143 — Relievant Medsystems RF Generator (August 18, 2017)