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510(k) K142950

Acrobat Calibrated Tip Wire Guide by Wilson-Cook Medical, Inc. — Product Code OCY

K142950 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Acrobat Calibrated Tip Wire Guide". The FDA issued a decision of Substantially Equivalent on November 5, 2014. The device falls under product code OCY (Endoscopic Guidewire, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2014
Date Received
October 10, 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 Wilson-Cook Medical, Inc.

  • K253302 — Hemospray Endoscopic Hemostat (HEMO-[X]) (June 2, 2026)
  • K251104 — SureTome™ SW Sphincterotome with DomeTip (September 29, 2025)
  • K243568 — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (January 17, 2025)
  • K213356 — Entuit PEG, Entuit PEGJ (January 20, 2022)
  • K212323 — Instinct Plus Endoscopic Clipping Device (August 25, 2021)
  • K201322 — Entuit Nasal Jejunal Feeding Tube (June 17, 2020)
  • K200972 — Hemospray Endoscopic Hemostat (June 10, 2020)
  • K200247 — Fusion Quattro Extraction Balloon (February 27, 2020)
  • K192339 — TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord (January 30, 2020)
  • K193344 — Tri-Ex Extraction Balloon with Multiple Sizing (December 13, 2019)

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)
  • 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