NOVAGOLD HIGH PERFORMANCE GUIDEWIRE— 510(k) K133076
Substantially EquivalentNeometrics, Inc.
FDA 510(k) clearance K133076 for NOVAGOLD HIGH PERFORMANCE GUIDEWIRE, Substantially Equivalent on 2014-02-20. Applicant: Neometrics, Inc.. Device class: 2.
Clearance details
- Applicant
- Neometrics, Inc.
- 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
- Plymouth, MN, US
Recent devices under product code OCY
view all- K153264 — EasyPass Guidewire
- K151471 — Radifocus Glidewire Endoscopic Wire
- 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
More clearances from Neometrics, Inc.
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 →
Recalls naming K133076
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133076.
Data sourced from openFDA. This site is unofficial and independent of the FDA.