FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
K Number: K021166
·
Decision May 9, 2002
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
10
Applicant Total
1
Review Days
28
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Basic Information
- Device Name
- ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
- K Number
- K021166
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acmi-Circon Corporation
- Date Received
- April 11, 2002
- Decision Date
- May 9, 2002
- Product Code
- FDC
- 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 |
|---|---|---|---|
| FDC | Resectoscope, Working Element | FDA class 2 | Gastroenterology, Urology |
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