Anesthesiology
Review Panel
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- ChemistryReview Panel
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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
- K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)2Cleared 510(K)
- K221874Altis Single Incision Sling System2Cleared 510(K)
- K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack2Cleared 510(K)
- K121562ALTIS SINGLE INCISION CLING SYSTEM2Cleared 510(K)
- K123179AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING2Cleared 510(K)
- K121641MINIARC PRO SINGLE-INCISION SLING SYSTEM2Cleared 510(K)
- K110420OPHIRA MINI SLING SYSTEM2Cleared 510(K)
- K103418DESARA MINI2Cleared 510(K)
- K100807MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 7201912Cleared 510(K)
- K092607AJUST ADJUSTABLE SINGLE INCISION SLING2Cleared 510(K)
Show All 20 Submissions
- 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
- Medical GeneticsReview Panel
- UnknownReview Panel
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K191416
- 510(k) Type
- Traditional
- Applicant
- Caldera Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/7/2020
- Days to Decision
- 255 days
- Submission Type
- Statement