LWEET CONE BIOPSY INSTRUMENT
FDA 510(k) clearance K961460 · decided 1996-11-19
Clearance details
- K-number
- K961460
- Device name
- LWEET CONE BIOPSY INSTRUMENT
- Applicant
- Apple Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-16
- Decision date
- 1996-11-19
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- HGI
- Device class
- 2
- Regulation number
- 884.4120
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Ringoes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fischer Cone Biopsy Excisor - Small Model: 900-150 recall (Z-0614-06) | Apple Medical Corporation | 2006-04-06 |
| Fischer Cone Biopsy Excisor - Medium Model: 900-151 recall (Z-0615-06) | Apple Medical Corporation | 2006-04-06 |
| Fischer Cone Biopsy Excisor - Large Model: 900-152 recall (Z-0616-06) | Apple Medical Corporation | 2006-04-06 |
| Fischer Cone Biopsy Excisor - Medium - Ext Model: 900-154 recall (Z-0617-06) | Apple Medical Corporation | 2006-04-06 |
| Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155 recall (Z-0618-06) | Apple Medical Corporation | 2006-04-06 |
| Fischer Cone Biopsy Excisor - Dual Sets Model: 900-156 recall (Z-0619-06) | Apple Medical Corporation | 2006-04-06 |
| Fischer Cone Biopsy Excisor Model: 900-157 recall (Z-0620-06) | Apple Medical Corporation | 2006-04-06 |
| Fischer Cone Biopsy Excisor Model: 900-158 recall (Z-0621-06) | Apple Medical Corporation | 2006-04-06 |