FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A
K Number: K091417
·
Decision May 22, 2009
Classifications
1
FEI Numbers
91
Registration Numbers
91
Same Product Code
42
Applicant Total
21
Review Days
9
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Basic Information
- Device Name
- SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A
- K Number
- K091417
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Corp.
- Date Received
- May 13, 2009
- Decision Date
- May 22, 2009
- Product Code
- OCY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- Y
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 |
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| K071075 | TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A | May 25, 2007 | Substantially Equivalent |
| K040783 | FOUNDATION | Oct 13, 2004 | Substantially Equivalent |
| K040210 | CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR | Mar 3, 2004 | Substantially Equivalent |
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