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510(k) K133076

NOVAGOLD HIGH PERFORMANCE GUIDEWIRE by Neometrics, Inc. — Product Code OCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2014
Date Received
September 30, 2013
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 Neometrics, Inc.

  • K152560 — Bard Snare Retrieval Kit (October 23, 2015)
  • K150225 — NovaGold High Performance Guidewire (March 16, 2015)
  • K143135 — Spring Coil Guidewire (February 20, 2015)
  • K123439 — NEO ERCP GUIDEWIRE (January 3, 2013)
  • K101729 — NEOWIRE PTA/PTCA GUIDEWIRE (September 23, 2010)
  • K070150 — VASCUPUNCTURE PICC GUIDEWIRE (February 15, 2007)
  • K043398 — MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE (March 1, 2005)
  • K040786 — VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING (April 19, 2004)
  • K033321 — SELECTIVA SB GUIDEWIRE (November 5, 2003)
  • K031652 — VASCUPUNCTURE PICC GUIDEWIRE (September 30, 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)
  • K131072 — ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE (July 9, 2013)
  • K124052 — OSTAVI HYDROPHILIC GUIDEWIRE (February 26, 2013)