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U.S. Department of Health and Human Services

Product Classification

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Device mesh, surgical, deployer
Regulation Description Surgical mesh.
Definition Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G.Hernia repair).
Physical State manual laparoscopic surgical instrument ;operation handle and deployment section.
Technical Method intended to facilitate hernia mesh delivery and placement during laparoscopic ventral hernia repair.
Target Area abdominal cavity
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeORQ
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 Type 510(k)
Regulation Number 878.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible