Absorbable Lung Biopsy Plug

Device Code: 223

Product Code(s): OMT

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 Classification Information

Device Type ID223
Device NameAbsorbable Lung Biopsy Plug
Physical StatePolymerized Hydrogel Plug, Cylindrical In Shape And Placed By A Deployment System Following Lung Biopsy By Smaller Biopsy Needle/instrument.
Technical MethodUpon Deployment Into A Lung Biopsy Tract, The Plug Expands To Fill The Biopsy Void Provide Closure Of The Biopsy Void.
Target AreaTo Be Used In The Lung, Specifically In Punctures Left By Percutenous, Transthoracic Needles
Regulation DescriptionAbsorbable Lung Biopsy Plug.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(k)
CFR Regulation Number878.4755 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOMT
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID223
DeviceAbsorbable Lung Biopsy Plug
Product CodeOMT
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAbsorbable Lung Biopsy Plug.
CFR Regulation Number878.4755 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Surgical Specialties Mexico S DE RL DE CV
II Oct-11-2016
TPLC Last Update: 2019-04-02 19:30:54

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