| Device |
absorbable lung biopsy plug |
| Regulation Description |
Absorbable lung biopsy plug. |
| Definition |
A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed. |
| Physical State |
Polymerized hydrogel plug, cylindrical in shape and placed by a deployment system following lung biopsy by smaller biopsy needle/instrument. |
| Technical Method |
Upon deployment into a lung biopsy tract, the plug expands to fill the biopsy void provide closure of the biopsy void. |
| Target Area |
to be used in the lung, specifically in punctures left by percutenous, transthoracic needles |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
Anesthesiology |
|---|
| Product Code | OMT |
|---|
| Premarket Review |
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4755
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
