FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYPODERMIC NEEDLES & STYLETS
K Number: K840033
·
Decision Apr 5, 1984
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
18
Review Days
91
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Basic Information
- Device Name
- HYPODERMIC NEEDLES & STYLETS
- K Number
- K840033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Microvasive
- Date Received
- January 5, 1984
- Decision Date
- April 5, 1984
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Microvasive
| K Number | Device Name | ||
|---|---|---|---|
| K872771 | LOW PROFILE GASTROSTOMY | Oct 9, 1987 | Substantially Equivalent |
| K870705 | THERMAL COAGULATOR | Apr 17, 1987 | Substantially Equivalent |
| K861309 | JEJUNAL FEEDING TUBE | Dec 16, 1986 | Substantially Equivalent |
| K861323 | REPLACEMENT GASTROSTOMY TUBE | Dec 16, 1986 | Substantially Equivalent |
| K860589 | INFLATOR/DEFLATOR PISTON SYRINGE | Apr 7, 1986 | Substantially Equivalent |
| K860366 | CHALLENGER HOT BIOPSY FORCEPS | Apr 7, 1986 | Substantially Equivalent |
| K854238 | NEEDLE W/STYLET FOR IMPLANTATION | Nov 13, 1985 | Substantially Equivalent |
| K854063 | MICROVASIVE SILICONE SPRAY | Oct 25, 1985 | Substantially Equivalent |
| K851652 | PAPILLOTOME | Jun 24, 1985 | Substantially Equivalent |
| K850393 | FLEXIBLE FIBEROPTIC ENDOSCOPE | Jun 4, 1985 | Substantially Equivalent |