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 B
| Device Type ID | 223 |
| Device Name | Absorbable Lung Biopsy Plug |
| 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 Description | Absorbable Lung Biopsy Plug. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4755 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OMT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 223 |
| Device | Absorbable Lung Biopsy Plug |
| Product Code | OMT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Absorbable Lung Biopsy Plug. |
| CFR Regulation Number | 878.4755 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Surgical Specialties Mexico S DE RL DE CV | II | Oct-11-2016 |