Anesthesiology
Review 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
- K253327HANAROSTENT Esophagus Upper (CCC)2Cleared 510(K)
- K243619Niti-S Esophageal Stent; Esophageal TTS Stent2Cleared 510(K)
- K251265Resilience Fully Covered Esophageal Stent System2Cleared 510(K)
- K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System2Cleared 510(K)
- K233837Agile Esophageal Stent System2Cleared 510(K)
- K240522Esophageal TTS Stent2Cleared 510(K)
- K223266Hilzo Esophageal Stents2Cleared 510(K)
- K221482Esophageal TTS Stent2Cleared 510(K)
- K211960Agile Esophageal OTW Stent System2Cleared 510(K)
- K213251HANAROSTENT Esophagus Asymmetric (CCC)2Cleared 510(K)
- K211706Esophageal TTS Stent2Cleared 510(K)
- K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)2Cleared 510(K)
- K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)2Cleared 510(K)
- K182910Segmented Esophageal Stent System2Cleared 510(K)
- K180144Agile Esophageal Stent System2Cleared 510(K)
- K172813Esophageal Stent System2Cleared 510(K)
- K162717Evolution Esophageal Stent System – Partially Covered2Cleared 510(K)
- K130004ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM2Cleared 510(K)
- K123205ESOPHAGEAL TTS STENT2Cleared 510(K)
- K120983ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM2Cleared 510(K)
- K113551ESOPHAGEAL TTS STENT2Cleared 510(K)
- K111611ENDOMAXX FULLY COVERED ESOPHAGEAL STENT2Cleared 510(K)
- K093619EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E2Cleared 510(K)
- K093537HANAROSTENT ESOPHAGUS (CCC)2Cleared 510(K)
- K092144BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR2Cleared 510(K)
- K091816ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM2Cleared 510(K)
- K091510WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M005167302Cleared 510(K)
- K080782NITI-S ESOPHAGEAL STENT2Cleared 510(K)
- K072094CHOOSTENT2Cleared 510(K)
- K080332POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 005143302Cleared 510(K)
- K080359EVOLUTION ESOPHAGEAL STENT SYSTEM2Cleared 510(K)
- K080838ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM2Cleared 510(K)
- K073266WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM2Cleared 510(K)
- K060239ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM2Cleared 510(K)
- K051621ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM2Cleared 510(K)
- K041648NITI-S STENT & INTRODUCER, MODEL EOXXXX2Cleared 510(K)
- K032930ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM2Cleared 510(K)
- K030559RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM2Cleared 510(K)
- K011591ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE2Cleared 510(K)
- K012883ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM2Cleared 510(K)
- K003173ASPIRE COVERED STENT AND DELIVERY CATHETER2Cleared 510(K)
- K010068RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM2Cleared 510(K)
- K002094BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE2Cleared 510(K)
- K984068FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS2Cleared 510(K)
- K983297MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE2Cleared 510(K)
- K973584MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM2Cleared 510(K)
- K955041INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM2Cleared 510(K)
- K955347ULTRAFLEX2Cleared 510(K)
- K941487INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS2Cleared 510(K)
- K945201COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT2Cleared 510(K)
- K940396WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)2Cleared 510(K)
- K940395WALLSTENT ESOPHAGEAL PROSTHESIS2Cleared 510(K)
- K940838MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM2Cleared 510(K)
- K920218ESOPHAGEAL Z-STENT2Cleared 510(K)
- K923119WALLSTENT ESOPHAGEAL PROTHESIS2Cleared 510(K)
- K914029ESOPHAGEAL Z-STENT2Cleared 510(K)
- K904821ELIACHAR MODIFIED ESOPHAGEAL STENT2Cleared 510(K)
- K885309WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS2Cleared 510(K)
- K871244HOOD ESOPHAGEAL PROSTHESIS2Cleared 510(K)
- 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
- 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
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- 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
HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K201160
- 510(k) Type
- Traditional
- Applicant
- M.I. Tech Co., Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/23/2021
- Days to Decision
- 449 days
- Submission Type
- Summary