FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
K Number: K090485
·
Decision Jul 22, 2009
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
37
Applicant Total
5
Review Days
147
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Basic Information
- Device Name
- COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
- K Number
- K090485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Percutaneous Systems, Incorporated
- Date Received
- February 25, 2009
- Decision Date
- July 22, 2009
- Product Code
- LQR
- 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 |
|---|---|---|---|
| LQR | Dislodger, Stone, Biliary | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Percutaneous Systems, Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K061766 | EXPRESSWAY INTERMITTENT CATHETER | Mar 9, 2007 | Substantially Equivalent |
| K052298 | CYSTOGLIDE INTRODUCER SHEATH | Dec 12, 2006 | Substantially Equivalent |
| K052048 | ACCORDION | Sep 13, 2005 | Substantially Equivalent |
| K042531 | UPDATED SLIP UROLOGY INTRODUCER SHEATH | Feb 1, 2005 | Substantially Equivalent |