FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTIPLE BIOPSY DEVICE-MBX
K Number: K911448
·
Decision Apr 16, 1991
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
12
Applicant Total
4
Review Days
32
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Basic Information
- Device Name
- MULTIPLE BIOPSY DEVICE-MBX
- K Number
- K911448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Triton Technology, Inc.
- Date Received
- March 15, 1991
- Decision Date
- April 16, 1991
- Product Code
- FCK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCK | Instrument, Biopsy, Suction | FDA class 2 | Gastroenterology, Urology |
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