Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- 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
- PAGMesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator2Product Code
- K090688COOK UROLOGICAL GRAFT2Cleared 510(K)
- K050445AMS COLLAGEN DERMAL MATRIX2Cleared 510(K)
- K042949PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)2Cleared 510(K)
- K031295BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM2Cleared 510(K)
- K030460MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX2Cleared 510(K)
- K020654STRATASIS SLING KIT2Cleared 510(K)
- K993459MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX2Cleared 510(K)
- K992159SURGISIS SLING2Cleared 510(K)
- K982403BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX2Cleared 510(K)
- 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
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- 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
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- UnknownReview Panel
COOK UROLOGICAL GRAFT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K090688
- 510(k) Type
- Traditional
- Applicant
- Cook Biotech, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/10/2009
- Days to Decision
- 116 days
- Submission Type
- Summary