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510(k) K080508

MANDREL GUIDEWIRES OR M-WIRE by Lake Region Medical — Product Code OCY

K080508 is an FDA 510(k) premarket notification submitted by Lake Region Medical for the device "MANDREL GUIDEWIRES OR M-WIRE". The FDA issued a decision of Substantially Equivalent on March 21, 2008. The device falls under product code OCY (Endoscopic Guidewire, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Lake Region Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2008
Date Received
February 25, 2008
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 Lake Region Medical

  • K253746 — Enroute 0.014'' Transcarotid Guidewire (March 19, 2026)
  • K242824 — PTFE Guidewire (December 6, 2024)
  • K221575 — Pre-Formed Blue (October 7, 2022)
  • K211741 — Pre-Formed Extra Support Guidewire (November 22, 2021)
  • K160643 — ENROUTE 0.014 Guidewire (October 18, 2016)
  • K151244 — Pre-Formed Guidewire (June 11, 2015)
  • K140536 — HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT (December 17, 2014)
  • K142393 — PREDICATE III GUIDEWIRE (November 25, 2014)
  • K142397 — Predicate III Guidewire (September 19, 2014)
  • K140482 — MANDREL GUIDEWIRE (April 8, 2014)

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