Panels › General, Plastic Surgery › Product code GCC · Class 1
Dilator, Catheter
Regulation 878.4200
0510(k)s in 12 months (5 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in GCC
| Company | 510(k)s | Recalls |
|---|---|---|
| DePuy Spine, Inc. | 0 | 5 |
| Med Institute, Inc. | 2 | 0 |
| Medical Engineering and Development Institute | 2 | 0 |
| Van-Tec, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2013 | DePuy Spine, Inc. PIPELINE LS ACCESS SYSTEM, Holding Clip
The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. Terminated |
GCC | None listed |
| Oct 23, 2013 | DePuy Spine, Inc. PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated
The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Terminated |
GCC | None listed |
| Oct 23, 2013 | DePuy Spine, Inc. PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated
The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Terminated |
GCC | None listed |
| Oct 23, 2013 | DePuy Spine, Inc. PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated
The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Terminated |
GCC | None listed |
| Oct 23, 2013 | DePuy Spine, Inc. PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated
The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Re Terminated |
GCC | None listed |
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