FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UPDATED SLIP UROLOGY INTRODUCER SHEATH
K Number: K042531
·
Decision Feb 1, 2005
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
63
Applicant Total
5
Review Days
137
Basic Information
- Device Name
- UPDATED SLIP UROLOGY INTRODUCER SHEATH
- K Number
- K042531
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PERCUTANEOUS SYSTEMS, INCORPORATED
- Date Received
- September 17, 2004
- Decision Date
- February 1, 2005
- Product Code
- KNY
- 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 |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by PERCUTANEOUS SYSTEMS, INCORPORATED
| K Number | Device Name | ||
|---|---|---|---|
| K090485 | COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 | Jul 22, 2009 | Substantially Equivalent |
| 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 |