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 | |||
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Manufacturer | Recall Class | Date Posted | |
1 | Surgical Specialties Mexico S DE RL DE CV | II | Oct-11-2016 |