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510(k) K153264

EasyPass Guidewire by Medi-Globe Corporation — Product Code OCY

K153264 is an FDA 510(k) premarket notification submitted by Medi-Globe Corporation for the device "EasyPass Guidewire". The FDA issued a decision of Substantially Equivalent on May 19, 2016. The device falls under product code OCY (Endoscopic Guidewire, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Medi-Globe Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2016
Date Received
November 12, 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 Medi-Globe Corporation

  • K142258 — PolyCatch Retrieval Device (September 30, 2014)
  • K133763 — SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM (May 15, 2014)
  • K091257 — MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM (May 8, 2009)
  • K083802 — SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27 (March 20, 2009)
  • K070129 — SONOTIP II ULTRASOUND NEEDLE SYSTEM (January 31, 2007)
  • K061684 — MEDI-GLOBE ROTA-CUT SPHINCTEROTOME (June 27, 2006)

Other clearances for product code OCY

  • 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)
  • K124052 — OSTAVI HYDROPHILIC GUIDEWIRE (February 26, 2013)

FDA data resources