FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED MODEL 2001 FIBER OPTICS CATHETER
K Number: K883881
·
Decision Oct 27, 1988
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
104
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- MODIFIED MODEL 2001 FIBER OPTICS CATHETER
- K Number
- K883881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1620
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Metatech Corp.
- Date Received
- July 29, 1988
- Decision Date
- October 27, 1988
- Product Code
- GWM
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | FDA class 2 | Neurology |
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Other Clearances by Metatech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K924314 | MOBILE STANDING FRAME | Feb 12, 1993 | Substantially Equivalent |
| K915370 | COPPER VAPOR LASER SYSTEM | Feb 7, 1992 | Substantially Equivalent |
| K903883 | VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES | Sep 19, 1990 | Substantially Equivalent |
| K890865 | HEXASCAN SCANNER HANDPIECE | Mar 24, 1989 | Substantially Equivalent |
| K883541 | METALASER VASCULASE | Nov 4, 1988 | Substantially Equivalent |
| K883518 | EVENT MARKER & A SECOND PRESSURE TREND OUTPUT | Sep 22, 1988 | Substantially Equivalent |
| K882552 | METATECH ROBINSON BOLT ACCESSORY | Sep 8, 1988 | Substantially Equivalent |
| K882367 | METATECH MICROCLIP APPLICATOR | Aug 25, 1988 | Substantially Equivalent |
| K882286 | EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET | Jul 18, 1988 | Substantially Equivalent |
| K881447 | METATECH METAL MICROCLIP | Jun 22, 1988 | Substantially Equivalent |