FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K Number: K093896
·
Decision Mar 25, 2010
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
25
Applicant Total
111
Review Days
97
Basic Information
- Device Name
- ETHICON ENDO SURGERY SLOTTED ANOSCOPE
- K Number
- K093896
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ETHICON ENDO-SURGERY, INC.
- Date Received
- December 18, 2009
- Decision Date
- March 25, 2010
- Product Code
- FER
- 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 |
|---|---|---|---|
| FER | Anoscope And Accessories | FDA class 2 | Gastroenterology, Urology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K091322 | CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G | Jun 1, 2009 | Substantially Equivalent |