FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
K Number: K082803
·
Decision Nov 13, 2008
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
51
Applicant Total
6
Review Days
50
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Basic Information
- Device Name
- COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
- K Number
- K082803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4680
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Percutaneous Systems, Inc.
- Date Received
- September 24, 2008
- Decision Date
- November 13, 2008
- Product Code
- FFL
- 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 |
|---|---|---|---|
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Percutaneous Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102887 | ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 | May 16, 2011 | Substantially Equivalent |
| K052134 | CYSTOGLIDE DILATING INTRODUCER SHEATH | Sep 22, 2005 | Substantially Equivalent |
| K042877 | MICROVERTER URETERAL ACCESS SHEATH | Nov 16, 2004 | Substantially Equivalent |
| K040519 | SLIP UROLOGY CATHETER | May 20, 2004 | Substantially Equivalent |
| K040520 | SLIP UROLOGY INTRODUCER SHEATH | May 20, 2004 | Substantially Equivalent |