Mesh, Surgical, Absorbable, Organ Support

Device Code: 5850

Product Code(s): OXL

Definition: For Reinforcement Of Soft Tissue Where Weakness Exists During Organ Support.

Device Classification Information

Device Type ID5850
Device NameMesh, Surgical, Absorbable, Organ Support
Physical StateAn Absorbable Mesh; Either Square, Rectangular, Round Or Of Various Other Shapes
Technical MethodAn Absorbable Mesh That Reinforces Soft Tissue
Target AreaVarious Organs In Need Of Temporary Support
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 CodeOXL
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5850
DeviceMesh, Surgical, Absorbable, Organ Support
Product CodeOXL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSurgical Mesh.
CFR Regulation Number878.3300 [🔎]
TPLC Last Update: 2019-04-02 21:13:23

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