Mesh, Surgical, Non-absorbable, Plastic And Reconstructive Surgery

Device Code: 5845

Product Code(s): OXG

Definition: For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.

Device Classification Information

Device Type ID5845
Device NameMesh, Surgical, Non-absorbable, Plastic And Reconstructive Surgery
Physical StateA Plastic Polymer Mesh; Either Square, Round, Rectangular Or Of Various Other Shapes.
Technical MethodA Non-absorbable Mesh That Reinforces Soft Tissue
Target AreaAreas In Need Of Plastic And Reconstructive Surgery
Regulation DescriptionSurgical Mesh.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type510(k)
CFR Regulation Number878.3300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOXG
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5845
DeviceMesh, Surgical, Non-absorbable, Plastic And Reconstructive Surgery
Product CodeOXG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSurgical Mesh.
CFR Regulation Number878.3300 [🔎]
TPLC Last Update: 2019-04-02 21:13:19

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