FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WHOLEY (TM) BIOPSY DEVICE
K Number: K874928
·
Decision Dec 30, 1987
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
47
Applicant Total
105
Review Days
28
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Basic Information
- Device Name
- WHOLEY (TM) BIOPSY DEVICE
- K Number
- K874928
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medrad, Inc.
- Date Received
- December 2, 1987
- Decision Date
- December 30, 1987
- Product Code
- GDM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDM | Needle, Aspiration And Injection, Reusable | FDA class 1 | General, Plastic Surgery |
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|---|---|---|---|
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| K113133 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE | Dec 15, 2011 | Substantially Equivalent |
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| K111182 | ANGIOJET SOLENT OMNI THROMBECTOMY SET | May 24, 2011 | Substantially Equivalent |
| K100798 | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C | Jun 23, 2010 | Substantially Equivalent |