Anesthesiology
Review Panel
- CardiovascularReview Panel
- 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
- K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System2Cleared 510(K)
- K201159WallFlex Colonic Stent System with Anchor Lock Delivery System2Cleared 510(K)
- K200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System2Cleared 510(K)
- K190141HANAROSTENT LowAx Colon/Rectum (NNN)2Cleared 510(K)
- K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)2Cleared 510(K)
- K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)2Cleared 510(K)
- K113510EVOLUTION COLONIC STENT SYSTEM2Cleared 510(K)
- K061877WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM2Cleared 510(K)
- K060323ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M005573802Cleared 510(K)
- K042065WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM2Cleared 510(K)
Show All 16 Submissions
- 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
- 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
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K180180
- 510(k) Type
- Traditional
- Applicant
- M.I. Tech Co., Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/2/2018
- Days to Decision
- 283 days
- Submission Type
- Summary