FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
K Number: K103726
·
Decision Feb 8, 2012
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
43
Applicant Total
65
Review Days
413
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Basic Information
- Device Name
- JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
- K Number
- K103726
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra LifeSciences Corporation
- Date Received
- December 22, 2010
- Decision Date
- February 8, 2012
- Product Code
- KNF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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