FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
K Number: K121370
·
Decision Aug 2, 2013
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
14
Applicant Total
3
Review Days
452
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Basic Information
- Device Name
- VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
- K Number
- K121370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vectec
- Date Received
- May 7, 2012
- Decision Date
- August 2, 2013
- Product Code
- FHO
- 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 |
|---|---|---|---|
| FHO | Pneumoperitoneum Needle | FDA class 2 | Gastroenterology, Urology |
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