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510(k) K212403

Tracheal Stent System (Y-Shaped) by Micro-Tech (Nanjing) Co., Ltd. — Product Code JCT

K212403 is an FDA 510(k) premarket notification submitted by Micro-Tech (Nanjing) Co., Ltd. for the device "Tracheal Stent System (Y-Shaped)". The FDA issued a decision of Substantially Equivalent on October 30, 2021. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Micro-Tech (Nanjing) Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2021
Date Received
August 2, 2021
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 Micro-Tech (Nanjing) Co., Ltd.

  • K252492 — Visualized Access and Delivery Catheter; PB Digital Controller (April 24, 2026)
  • K251692 — Advanced Tissue Resection Device (February 21, 2026)
  • K250229 — Dual Action Tissue Closure Device (September 8, 2025)
  • K243388 — Disposable Distal Cap (June 27, 2025)
  • K243471 — Extraction Basket (December 16, 2024)
  • K230127 — Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent S (September 6, 2023)
  • K221784 — Single-use Video Pancreaticobiliary Scope, PB Digital Controller (February 16, 2023)
  • K222354 — Elastic Traction System (October 3, 2022)
  • K213060 — AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultr (July 20, 2022)
  • K220424 — Through the Scope Tracheal Stent System (July 8, 2022)

Other clearances for product code JCT

  • K230269 — Ultraflex™ Tracheobronchial Stent System (July 14, 2023)
  • K220424 — Through the Scope Tracheal Stent System (July 8, 2022)
  • 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)
  • K140472 — BONASTENT TRACHEAL / BRONCHIAL (October 17, 2014)
  • K141584 — ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM (October 16, 2014)
  • K121048 — ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED (August 3, 2012)

FDA data resources