FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESOPHAGEAL Z-STENT
K Number: K920218
·
Decision Feb 9, 1994
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
58
Applicant Total
125
Review Days
755
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Basic Information
- Device Name
- ESOPHAGEAL Z-STENT
- K Number
- K920218
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wilson-Cook Medical, Inc.
- Date Received
- January 16, 1992
- Decision Date
- February 9, 1994
- Product Code
- ESW
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| ESW | Prosthesis, Esophageal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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Esophageal TTS Stent
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