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
- K242960AdVance™ XP Male Sling System (720163-03)2Cleared 510(K)
- K231891Virtue Male Sling System with Alexis Wound Retractor Convenience Kit2Cleared 510(K)
- K211847AdVance XP Male Sling System2Cleared 510(K)
- K182169AdVance XP Male Sling2Cleared 510(K)
- K113496VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT2Cleared 510(K)
- K111881VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT2Cleared 510(K)
- K101297VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 500202Cleared 510(K)
- K091152VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 500202Cleared 510(K)
- K082640VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM2Cleared 510(K)
- K063079I-STOP TRANS OBTURATOR MALE SLING2Cleared 510(K)
Show All 12 Submissions
- 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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Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K231891
- 510(k) Type
- Traditional
- Applicant
- Coloplast
- Country
- United States
- FDA Decision
- Substantially Equivalent - Kit
- Decision Date
- 9/25/2023
- Days to Decision
- 90 days
- Submission Type
- Summary