FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM
K Number: K131614
·
Decision Aug 29, 2013
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
36
Applicant Total
130
Review Days
87
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Basic Information
- Device Name
- REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM
- K Number
- K131614
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Covidien
- Date Received
- June 3, 2013
- Decision Date
- August 29, 2013
- Product Code
- NUJ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | FDA class 2 | General, Plastic Surgery |
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