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510(k) K140472

BONASTENT TRACHEAL / BRONCHIAL by Endochoice, Inc. — Product Code JCT

K140472 is an FDA 510(k) premarket notification submitted by Endochoice, Inc. for the device "BONASTENT TRACHEAL / BRONCHIAL". The FDA issued a decision of Substantially Equivalent on October 17, 2014. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Endochoice, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2014
Date Received
February 25, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tracheal, Expandable
Device Class
Class II
Regulation Number
878.3720
Review Panel
AN
Submission Type

Other clearances by Endochoice, Inc.

  • K160275 — Fuse Endoscopic System with FuseBox Processor (August 1, 2016)
  • K161482 — EndoChoice Water Bottle Cap Irrigation System (June 27, 2016)
  • K161167 — Seal Single-Use Biopsy Valve (May 26, 2016)
  • K160403 — SmartStart Air/Water and Suction Valves (May 19, 2016)
  • K153588 — EndoChoice Water Bottle Cap System (February 24, 2016)
  • K151475 — EndoChoice Select Injection Needle (February 8, 2016)
  • K152182 — Fuse Gastroscopy System (December 10, 2015)
  • K152580 — rescuenet (November 3, 2015)
  • K142155 — ENDOCHOICE WATER BOTTLE CAP SYSTEM (January 20, 2015)
  • K141598 — FUSE COLONOSCOPY SYSTEM (September 30, 2014)

Other clearances for product code JCT

  • K230269 — Ultraflex™ Tracheobronchial Stent System (July 14, 2023)
  • K220424 — Through the Scope Tracheal Stent System (July 8, 2022)
  • K212403 — Tracheal Stent System (Y-Shaped) (October 30, 2021)
  • K202204 — Tracheal Stent System (September 1, 2021)
  • K201342 — HANAROSTENT Trachea/Bronchium (CCC) (December 31, 2020)
  • K181200 — AEROmini Tracheobronchial Stent System (September 21, 2018)
  • K152842 — WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOB (May 19, 2016)
  • K140382 — AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY (November 25, 2014)
  • K141584 — ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM (October 16, 2014)
  • K121048 — ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED (August 3, 2012)

FDA data resources