FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTEGRA
K Number: K053640
·
Decision Mar 1, 2006
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
55
Applicant Total
22
Review Days
61
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Basic Information
- Device Name
- INTEGRA
- K Number
- K053640
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5990
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Direx Systems Corp.
- Date Received
- December 30, 2005
- Decision Date
- March 1, 2006
- Product Code
- LNS
- 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 |
|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LNS), ordered by most recent decision date.
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Other Clearances by Direx Systems Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K111947 | DUET MAGNA | Mar 1, 2012 | Substantially Equivalent |
| K102765 | PRONEX | Dec 7, 2010 | Substantially Equivalent |
| K072529 | TRACKPORT | Oct 26, 2007 | Substantially Equivalent |
| K071701 | TRACKLEAF-10 | Jul 23, 2007 | Substantially Equivalent |
| K063482 | CROSSPLAN / ACCUSOFT-XL V.4.04 | Dec 14, 2006 | Substantially Equivalent |
| K062147 | INTEGRA SL | Oct 20, 2006 | Substantially Equivalent |
| K062032 | ACCUSOFT, ACCUSOFT XL | Oct 5, 2006 | Substantially Equivalent |
| K061873 | VERT-X | Aug 18, 2006 | Substantially Equivalent |
| K061713 | MAGIS1;MAGIS2 | Jul 21, 2006 | Substantially Equivalent |
| K052212 | MIGUE | Mar 10, 2006 | Substantially Equivalent |