Anesthesiology
Review Panel
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- ChemistryReview Panel
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- 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
- K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System2Cleared 510(K)
- K222293ArcSP Suprapubic Sling System2Cleared 510(K)
- K222468ArcTO Transobturator Sling System2Cleared 510(K)
- K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System2Cleared 510(K)
- K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System2Cleared 510(K)
- K210087Athena Surgical RMUS System2Cleared 510(K)
- K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide2Cleared 510(K)
- K183134ArcTV Transvaginal Sling System2Cleared 510(K)
- K162201Desara TV, Desara Blue TV2Cleared 510(K)
- K140843DESARA BLUE OV, DESARA BLUE SS2Cleared 510(K)
- K131229SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS2Cleared 510(K)
- K132655RETROARC RETROPUBIC SLING SYSTEM2Cleared 510(K)
- K132069DESARA MESH, DESARA BLUE2Cleared 510(K)
- K132054GYNECARE TVT EXACT CONTINENCE SYSTEM2Cleared 510(K)
- K121928DESARA SL2Cleared 510(K)
- K121754BLUE SUI SLING2Cleared 510(K)
- K103022KIM2Cleared 510(K)
- K112609DESARA MESH2Cleared 510(K)
- K111219GMD UNIVERSAL URINARY INCONTINENCE SLING2Cleared 510(K)
- K111233SUPRIS RETROPUBIC SLING SYSTEM2Cleared 510(K)
- K100936GYNECARE TVT ABBREVO CONTINENCE SYSTEM2Cleared 510(K)
- K101440GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 10122Cleared 510(K)
- K101169DESARA MESH MODEL: CAL-DS012Cleared 510(K)
- K093747ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS2Cleared 510(K)
- K100485GYNECARE TVT EXACT CONTINENCE SYSTEM2Cleared 510(K)
- K092203OMNISURE URETHRAL SLING, MODEL OTK522Cleared 510(K)
- K083471GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 10202Cleared 510(K)
- K081613SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS2Cleared 510(K)
- K072456DESARA MESH SLING, MODEL CAL-DS012Cleared 510(K)
- K073647MINITAPE EXTRA URETHRAL SLING2Cleared 510(K)
- K070073ALIGN URETHRAL SUPPORT SYSTEM2Cleared 510(K)
- K063713AMS SMART SLING SYSTEM2Cleared 510(K)
- K050516T-SLING2Cleared 510(K)
- K053296MENTOR ARIS SUPRAPUBIC SURGICAL KIT2Cleared 510(K)
- K052175I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-40002Cleared 510(K)
- K051533I-STOP2Cleared 510(K)
- K051530MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.2Cleared 510(K)
- K050148MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT2Cleared 510(K)
- K042592INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 724033042Cleared 510(K)
- K042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT2Cleared 510(K)
- K041948SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS2Cleared 510(K)
- K041176URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM2Cleared 510(K)
- K040787MODIFICATION TO SURGICAL MESH POLYMERIC2Cleared 510(K)
- K040538BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 724039962Cleared 510(K)
- K033310REMEEX SYSTEM FOR URINARY INCONTINENCE2Cleared 510(K)
- K033691SAFYRE VS AND SAFYRE T2Cleared 510(K)
- K033568GYNECARE TVT OBTURATOR SYSTEM2Cleared 510(K)
- K031767MENTOR OBTAPE TRANS-OBTURATOR TAPE2Cleared 510(K)
- K030123BIOARC SP SLING KIT2Cleared 510(K)
- K023516MONARC SLING SYSTEM2Cleared 510(K)
- K021263MODIFICATION TO SPARC SLING SYSTEM2Cleared 510(K)
- K020705SIIS#1 TISSUE SUSPENSION SYSTEM2Cleared 510(K)
- K020110MODIFICATION TO TRELEX MESH SURGICAL MESH2Cleared 510(K)
- K020663MODIFICATION TO SPARC SLING SYSTEM2Cleared 510(K)
- K020007SAFYRE SLING SYSTEM2Cleared 510(K)
- K013355SPARC SLING SYSTEM2Cleared 510(K)
- K012628GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM2Cleared 510(K)
- K012949URETEX SUP PUBOURETHRAL SLING2Cleared 510(K)
- K011251SPARC SLING SYSTEM2Cleared 510(K)
- K982042ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.0022Cleared 510(K)
- K980482TRIANGLE SLING2Cleared 510(K)
- K974098PUBOUURETHRAL SLING2Cleared 510(K)
- K973022ISLAND BIOSURGICAL INC. BNS KIT #1 & #22Cleared 510(K)
- K972651IN-SLING2Cleared 510(K)
- K960101ISLAND BIOSURGICAL BOLSTER2Cleared 510(K)
- 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
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K040538
- 510(k) Type
- Special
- Applicant
- AMERICAN MEDICAL SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/17/2004
- Days to Decision
- 15 days
- Submission Type
- Summary