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510(k) K023603

ENDO-GLIDE GUIDEWIRE by Endo-Therapeutics, Inc. — Product Code OCY

K023603 is an FDA 510(k) premarket notification submitted by Endo-Therapeutics, Inc. for the device "ENDO-GLIDE GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on February 19, 2003. The device falls under product code OCY (Endoscopic Guidewire, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Endo-Therapeutics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2003
Date Received
October 28, 2002
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 Endo-Therapeutics, Inc.

  • K090796 — MULTI-BITE HOT BIOPSY FORCEPS (November 25, 2009)
  • K031026 — ETI BIPOLAR HEMOSTATIC PROBE (June 27, 2003)
  • K012725 — TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGER (November 8, 2001)
  • K012977 — VARICES INJECTION NEEDLE (November 2, 2001)
  • K926549 — ENDOCATH ELECTROPHYSIOLOGY CATHETER (December 6, 1993)
  • K925392 — BIOPSY FORCEPS (November 5, 1993)

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