FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEEDLE GUIDE/GRID
K Number: K973362
·
Decision Oct 1, 1997
Classifications
1
FEI Numbers
388
Registration Numbers
389
Same Product Code
407
Applicant Total
9
Review Days
23
Basic Information
- Device Name
- NEEDLE GUIDE/GRID
- K Number
- K973362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PROTEK MEDICAL PRODUCTS, INC.
- Date Received
- September 8, 1997
- Decision Date
- October 1, 1997
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
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Other Clearances by PROTEK MEDICAL PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K973958 | GENERAL PURPOSE ATL NEEDLE GUIDE KIT | Jan 22, 1998 | Substantially Equivalent |
| K973622 | TRANSDUCER POSITIONER | Nov 26, 1997 | Substantially Equivalent |
| K970893 | ULTRASOUND TRANSDUCER DRAPE | Oct 20, 1997 | Substantially Equivalent |
| K970889 | ULTRASOUND TRANSDUCER DRAPE | Oct 20, 1997 | Substantially Equivalent |
| K970885 | ULTRASOUND SYSTEMS DRAPE | Sep 22, 1997 | Substantially Equivalent |
| K970891 | DRAPE, SURGICAL-LATEX | Aug 22, 1997 | Substantially Equivalent |
| K971722 | TRANS VAGINAL NEEDLE GUIDE | Jul 10, 1997 | Substantially Equivalent |
| K971115 | GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE | Jun 13, 1997 | Substantially Equivalent |