Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- FAEProsthesis, Penile2Product Code
- FAFProsthesis, Testicular3Product Code
- FHWDevice, Impotence, Mechanical/Hydraulic3Product Code
- FTOProsthesis, Testicle3Product Code
- FTQProsthesis, Penis, Rigid Rod2Product Code
- JCWProsthesis, Penis, Inflatable3Product Code
- QGAPenile Implant Surgical Accessories1Product Code
- ESWProsthesis, Esophageal2Product Code
- MQRStent, Colonic, Metallic, Expandable2Product Code
- MUMStent, Metallic, Expandable, Duodenal2Product Code
- OTMMesh, Surgical, For Stress Urinary Incontinence, Male2Product Code
- OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator2Product Code
- PAGMesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator2Product Code
- PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling2Product Code
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
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Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- Page Type
- Product Code
- Definition
- Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
- Physical State
- synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured or can be a sheet to allow surgeon to cut mesh to desired size and shap
- Technical Method
- placed under the urethra transvaginally using a transobturator (one vaginal incision and two groin/upper thigh incisions) or retropubic (one vaginal incision and two abdominal incisions) approach; during instances of increased abdominal pressure (e.g., coughing, laughing, sneezing, etc.) the device applies pressure to the urethra to prevent urine leakage
- Target Area
- urethra, vagina
- Regulation Medical Specialty
- General and Plastic Surgery
- Review Panel
- Gastroenterology and Urology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 878.3300
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 878.3300 Surgical mesh
§ 878.3300 Surgical mesh.
(a) Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
(b) Classification. Class II.