FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
K Number: K861629
·
Decision Aug 12, 1986
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
60
Review Days
105
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Basic Information
- Device Name
- KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
- K Number
- K861629
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Downs Surgical , Ltd.
- Date Received
- April 29, 1986
- Decision Date
- August 12, 1986
- Product Code
- HAW
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Downs Surgical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | Oct 31, 1990 | Substantially Equivalent |
| K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | Oct 31, 1990 | Substantially Equivalent |
| K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | Oct 31, 1990 | Substantially Equivalent |
| K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | Oct 31, 1990 | Substantially Equivalent |
| K900611 | SHEPPERD DILATATION TUBE SET (GS-501-20-H) | Oct 22, 1990 | Substantially Equivalent |
| K900614 | SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V) | Oct 22, 1990 | Substantially Equivalent |
| K900612 | SHEPPERD TREPHINE SET (GS-501-30-V) | Oct 22, 1990 | Substantially Equivalent |
| K900610 | SHEPPERD CANNULA STILLETTE & OBDURATOR SET | Oct 22, 1990 | Substantially Equivalent |
| K900616 | SHEPPERD CUTTING FORCEPS | Oct 22, 1990 | Substantially Equivalent |
| K900609 | SHEPPERD STRAIGHT AND CURVED NEEDLES | Oct 22, 1990 | Substantially Equivalent |