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510(k) K142397

Predicate III Guidewire by Lake Region Medical — Product Code OCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2014
Date Received
August 27, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Guidewire, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.

Other clearances by Lake Region Medical

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  • K160643 — ENROUTE 0.014 Guidewire (October 18, 2016)
  • K151244 — Pre-Formed Guidewire (June 11, 2015)
  • K140536 — HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT (December 17, 2014)
  • K142393 — PREDICATE III GUIDEWIRE (November 25, 2014)
  • K140482 — MANDREL GUIDEWIRE (April 8, 2014)
  • K133155 — HYDROPHILIC COATED GUIDEWIRE (April 7, 2014)
  • K140485 — MANDREL GUIDEWIRE (March 27, 2014)

Other clearances for product code OCY

  • K153264 — EasyPass Guidewire (May 19, 2016)
  • K151471 — Radifocus Glidewire Endoscopic Wire (September 17, 2015)
  • K150927 — Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire (May 27, 2015)
  • K150225 — NovaGold High Performance Guidewire (March 16, 2015)
  • K142950 — Acrobat Calibrated Tip Wire Guide (November 5, 2014)
  • K141820 — JAGWIRE HIGH PERFORMANCE GUIDWIRE (October 21, 2014)
  • K140482 — MANDREL GUIDEWIRE (April 8, 2014)
  • K133076 — NOVAGOLD HIGH PERFORMANCE GUIDEWIRE (February 20, 2014)
  • K131072 — ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE (July 9, 2013)
  • K124052 — OSTAVI HYDROPHILIC GUIDEWIRE (February 26, 2013)