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510(k) K091417

SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A by Terumo Corp. — Product Code OCY

K091417 is an FDA 510(k) premarket notification submitted by Terumo Corp. for the device "SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A". The FDA issued a decision of Substantially Equivalent on May 22, 2009. The device falls under product code OCY (Endoscopic Guidewire, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Terumo Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2009
Date Received
May 13, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Corp.

  • K100282 — TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER (February 26, 2010)
  • K092372 — HEARTRAIL III GUIDING CATHETER (September 11, 2009)
  • K090973 — TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) (May 1, 2009)
  • K073474 — CAPIOX CIRCUIT CONNECTORS (March 5, 2008)
  • K071572 — CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER (July 23, 2007)
  • K071494 — CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER (July 16, 2007)
  • K071075 — TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A (May 25, 2007)
  • K040783 — FOUNDATION (October 13, 2004)
  • K040210 — CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR (March 3, 2004)
  • K033681 — GLIDESHEATH (December 11, 2003)

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)
  • 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)

FDA data resources