FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
K Number: K952350
·
Decision Jul 17, 1995
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
2
Applicant Total
5
Review Days
59
Basic Information
- Device Name
- JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
- K Number
- K952350
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PROMEDICAL LTD.
- Date Received
- May 19, 1995
- Decision Date
- July 17, 1995
- Product Code
- LWE
- Advisory Committee
- Unknown
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LWE | Bone Marrow Collection/Transfusion Kit | FDA class 2 | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LWE), ordered by most recent decision date.
BONE-TEMNO/STERNUM-TEMNO
FDA 510(k)
FDA Class 2
·Unknown
BONE MARROW COLLECTION KIT AND STAND
FDA 510(k)
FDA Class 2
·Unknown
Other Clearances by PROMEDICAL LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K954596 | PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM | Oct 7, 1995 | Substantially Equivalent |
| K951598 | PRO-B BIOPSY NEEDLE | Apr 21, 1995 | Substantially Equivalent |
| K944944 | CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE | Dec 21, 1994 | Substantially Equivalent |
| K944942 | BREAST LESION LOCALIZATION NEEDLE | Nov 4, 1994 | Substantially Equivalent |