Home / 510(k) Clearances / K021179

510(k) K021179

DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A by Olympus Optical Co., Ltd. — Product Code OCY

K021179 is an FDA 510(k) premarket notification submitted by Olympus Optical Co., Ltd. for the device "DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A". The FDA issued a decision of Substantially Equivalent on July 5, 2002. The device falls under product code OCY (Endoscopic Guidewire, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Olympus Optical Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2002
Date Received
April 15, 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 Olympus Optical Co., Ltd.

  • K033225 — EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND AN (October 16, 2003)
  • K031305 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (September 23, 2003)
  • K031648 — VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (July 24, 2003)
  • K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (July 16, 2003)
  • K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 (May 9, 2003)
  • K024138 — HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE (March 12, 2003)
  • K021852 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES (February 11, 2003)
  • K022445 — VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (January 24, 2003)
  • K024033 — XTJF-160AF DUODENOVIDEOSCOPE (December 20, 2002)
  • K023280 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES (December 19, 2002)

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