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510(k) K151471

Radifocus Glidewire Endoscopic Wire by Terumo Medical Corporation — Product Code OCY

K151471 is an FDA 510(k) premarket notification submitted by Terumo Medical Corporation for the device "Radifocus Glidewire Endoscopic Wire". The FDA issued a decision of Substantially Equivalent on September 17, 2015. The device falls under product code OCY (Endoscopic Guidewire, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Terumo Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2015
Date Received
June 1, 2015
Clearance Type
Traditional
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 Terumo Medical Corporation

  • K231044 — R2P Navicross (July 27, 2023)
  • K213531 — TR BAND Radial Compression Device (December 20, 2021)
  • K193125 — R2P Destination Slender Guiding Sheath (January 6, 2020)
  • K181237 — Glidesheath Slender Tibial Pedal Kit (August 3, 2018)
  • K173831 — Glidesheath Slender (May 8, 2018)
  • K172995 — Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Desti (November 21, 2017)
  • K171491 — R2P Destination Slender Guiding Sheath (October 5, 2017)
  • K152173 — Glidesheath (December 1, 2015)
  • K152525 — TR BAND Radial Compression Device (November 10, 2015)
  • K142183 — GLIDESHEATH SLENDER (November 21, 2014)

Other clearances for product code OCY

  • K153264 — EasyPass Guidewire (May 19, 2016)
  • 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)
  • K142397 — Predicate III Guidewire (September 19, 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)

FDA data resources