FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
K Number: K050304
·
Decision Mar 8, 2005
Classifications
1
FEI Numbers
91
Registration Numbers
91
Same Product Code
42
Applicant Total
92
Review Days
28
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
- K Number
- K050304
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Conmedcorp
- Date Received
- February 8, 2005
- Decision Date
- March 8, 2005
- Product Code
- OCY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCY), ordered by most recent decision date.
EasyPass Guidewire
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Radifocus Glidewire Endoscopic Wire
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NovaGold High Performance Guidewire
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Acrobat Calibrated Tip Wire Guide
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JAGWIRE HIGH PERFORMANCE GUIDWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Conmedcorp
| K Number | Device Name | ||
|---|---|---|---|
| K101534 | CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM | Nov 24, 2010 | Substantially Equivalent |
| K061021 | ENTAKE STANDARD AND SAFETY PEG SYSTEM | Apr 28, 2006 | Substantially Equivalent |
| K050992 | CONMED IRRIGATION NOZZLE | Jul 14, 2005 | Substantially Equivalent |
| K050777 | PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 | Apr 22, 2005 | Substantially Equivalent |
| K041953 | VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART | Aug 9, 2004 | Substantially Equivalent |
| K021079 | ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX | Jul 1, 2002 | Substantially Equivalent |
| K021299 | CONMED HEATWAVE HAND-CONTROLLED ELETRODE | Jun 26, 2002 | Substantially Equivalent |
| K020135 | CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120 | Apr 12, 2002 | Substantially Equivalent |
| K020186 | CONMED SYSTEM 5000 ESU | Apr 12, 2002 | Substantially Equivalent |
| K002002 | SUREFIT DISPERSIVE ELECTRODE | Aug 17, 2000 | Substantially Equivalent |