SAFETY BIOPSY NEEDLE SYSTEM
FDA 510(k) clearance K140137 · decided 2014-03-25
Clearance details
- K-number
- K140137
- Device name
- SAFETY BIOPSY NEEDLE SYSTEM
- Applicant
- Pfm Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-22
- Decision date
- 2014-03-25
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Carlsbad, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NIT-OCCLUD PDA (P120009/S004) | Pfm Medical, Inc. | 2024-10-17 |
| PMA NIT-OCCLUD PDA (P120009/S003) | Pfm Medical, Inc. | 2016-12-16 |
| NIT-OCCLUD SYSTEM (P120009/S002) | Pfm Medical, Inc. | 2015-01-21 |
| NIT-OCCLUD PDA (P120009/S001) | Pfm Medical, Inc. | 2014-08-01 |
| NIT-OCCLUD PDA (P120009) | Pfm Medical, Inc. | 2013-08-16 |