HYPODERMIC NEEDLES & STYLETS
FDA 510(k) clearance K840033 · decided 1984-04-05
Clearance details
- K-number
- K840033
- Device name
- HYPODERMIC NEEDLES & STYLETS
- Applicant
- Microvasive
- Decision
- Substantially Equivalent
- Date received
- 1984-01-05
- Decision date
- 1984-04-05
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Manual Biopsy Devices containing AIM system: Crown Biopsy Needle: 6 inch/15 cm, 22 gauge, recall (Z-1444-04) | Boston Scientific Corporation | 2004-09-14 |
| Manual Biopsy Devices containing AIM system: Co-Axial Lung Biopsy Needle, 6 inch/15 cm, 22 recall (Z-1445-04) | Boston Scientific Corporation | 2004-09-14 |