JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
FDA 510(k) clearance K952350 · decided 1995-07-17
Clearance details
- K-number
- K952350
- Device name
- JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
- Applicant
- Promedical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-19
- Decision date
- 1995-07-17
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- LWE
- Device class
- 2
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Wyckoff, NJ, US
- Third-party review
- No
- 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.
| Record | Firm | Date |
|---|---|---|
| BONE-TEMNO/STERNUM-TEMNO (K913306) | Proact, Ltd. | 1991-11-01 |
| BONE MARROW COLLECTION KIT AND STAND (K871198) | Baxter Healthcare Corp | 1987-11-06 |
Recalls involving this device
No recalls on record reference this clearance.