FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVID-NIT NERVE STIMULATION NEEDLES
K Number: K014246
·
Decision Jul 16, 2002
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
9
Review Days
202
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Basic Information
- Device Name
- AVID-NIT NERVE STIMULATION NEEDLES
- K Number
- K014246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Avid N.I.T., Inc.
- Date Received
- December 26, 2001
- Decision Date
- July 16, 2002
- Product Code
- CAZ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | FDA class 2 | Anesthesiology |
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Other Clearances by Avid N.I.T., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013231 | AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L | Dec 3, 2001 | Substantially Equivalent |
| K983218 | N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE | Nov 6, 1998 | Substantially Equivalent |
| K972595 | ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER | May 20, 1998 | Substantially Equivalent |
| K972554 | REGANES RADIONUCLIDE SEED MAGAZINE | Feb 17, 1998 | Substantially Equivalent |
| K973037 | N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 | Jan 27, 1998 | Substantially Equivalent |
| K973638 | N.I.T., INC. NEEDLE GUIDING TEMPLATE | Dec 23, 1997 | Substantially Equivalent |
| K971645 | REGANES SPINAL NEEDLE (VARIOUS) | Aug 1, 1997 | Substantially Equivalent |
| K945965 | ATRAUMATIC PENCIL POINT SPINAL NEEDLE | Aug 2, 1995 | Substantially Equivalent |