PROSTATE BIOPSY NEEDLE
FDA 510(k) clearance K982401 · decided 1998-09-08
Clearance details
- K-number
- K982401
- Device name
- PROSTATE BIOPSY NEEDLE
- Applicant
- Remington Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-10
- Decision date
- 1998-09-08
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medica recall (Z-0028-2013) | Remington Medical Inc. | 2012-10-09 |
| Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene steril recall (Z-0673-2007) | Remington Medical Inc. | 2007-03-29 |
| Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Eth recall (Z-0697-05) | Remington Medical Inc. | 2005-04-08 |