FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSTAT ELECTROSURGICAL UNIT
K Number: K913881
·
Decision Nov 1, 1991
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
180
Applicant Total
5
Review Days
64
Basic Information
- Device Name
- ENDOSTAT ELECTROSURGICAL UNIT
- K Number
- K913881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MEDICAL AND SCIENTIFIC ENTERPRISES, INC.
- Date Received
- August 29, 1991
- Decision Date
- November 1, 1991
- Product Code
- KNS
- 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 |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
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