Radifocus Glidewire Endoscopic Wire— 510(k) K151471
Substantially EquivalentTerumo Medical Corporation
FDA 510(k) clearance K151471 for Radifocus Glidewire Endoscopic Wire, Substantially Equivalent on 2015-09-17. Applicant: Terumo Medical Corporation. Device class: 2.
Clearance details
- Applicant
- Terumo Medical Corporation
- Product code
- Code OCY
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerset, NJ, US
Recent devices under product code OCY
view all- K153264 — EasyPass Guidewire
- K150927 — Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
- K150225 — NovaGold High Performance Guidewire
- K142950 — Acrobat Calibrated Tip Wire Guide
- K141820 — JAGWIRE HIGH PERFORMANCE GUIDWIRE
More clearances from Terumo Medical Corporation
view allAdverse events under product code OCY
product code OCY- Injury
- 186
- Malfunction
- 578
- Total
- 764
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.