BIP BIOPSY NEEDLE MODIFICATION
FDA 510(k) clearance K934370 · decided 1994-03-07
Clearance details
- K-number
- K934370
- Device name
- BIP BIOPSY NEEDLE MODIFICATION
- Applicant
- Bip USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-07
- Decision date
- 1994-03-07
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Niagara Falls, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 recall (Z-3206-2024) | Bard Peripheral Vascular Inc | 2024-09-20 |
| Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1610. Bard Magnum Di recall (Z-0273-2010) | Bard Peripheral Vascular Inc | 2009-11-17 |
| Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1613. Bard Magnum Di recall (Z-0274-2010) | Bard Peripheral Vascular Inc | 2009-11-17 |
| Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616. Bard Magnum Di recall (Z-0275-2010) | Bard Peripheral Vascular Inc | 2009-11-17 |
| Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1620. Bard Magnum Di recall (Z-0276-2010) | Bard Peripheral Vascular Inc | 2009-11-17 |