FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
K Number: K972979
·
Decision Dec 11, 1997
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
18
Applicant Total
529
Review Days
122
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Basic Information
- Device Name
- SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
- K Number
- K972979
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- August 11, 1997
- Decision Date
- December 11, 1997
- Product Code
- FBO
- 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 |
|---|---|---|---|
| FBO | Cystourethroscope | FDA class 2 | Gastroenterology, Urology |
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