FDA 510(k)
FDA class 2
Unknown
🇮🇪 Ireland
ContainOR
K Number: DEN170075
·
Decision Dec 19, 2017
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
3
Review Days
81
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Basic Information
- Device Name
- ContainOR
- K Number
- DEN170075
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 878.4825
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Advanced Surgical Concepts, Ltd.
- Date Received
- September 29, 2017
- Decision Date
- December 19, 2017
- Product Code
- PZQ
- 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 |
|---|---|---|---|
| PZQ | General Laparoscopic Power Morcellation Containment System | FDA class 2 | General, Plastic Surgery |