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510(k) K971509

ENDOXANE by Novatech SA — Product Code NWA

K971509 is an FDA 510(k) premarket notification submitted by Novatech SA for the device "ENDOXANE". The FDA issued a decision of ST on August 21, 1997. The device falls under product code NWA (Prosthesis, Tracheal, Preformed/Molded), a Class II device regulated under 21 CFR 878.3720. Novatech SA has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
August 21, 1997
Date Received
April 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tracheal, Preformed/Molded
Device Class
Class II
Regulation Number
878.3720
Review Panel
AN
Submission Type

The device is intended to provide support to weakened or constricting airway walls.

Other clearances by Novatech SA

  • K242324 — DUTAU-NOVATECH® (February 6, 2025)
  • K243126 — TRACHEOBRONXANE™ DUMON® (October 29, 2024)
  • K170030 — NOVATECH TALCAIR (March 13, 2017)
  • K151832 — NOVATECH TALCAIR (March 31, 2016)

Other clearances for product code NWA

  • K261541 — VisionAir Enhanced Stock Stent (June 1, 2026)
  • K243126 — TRACHEOBRONXANE™ DUMON® (October 29, 2024)
  • K213969 — VisionAir Patient-Specific Airway Stent (October 7, 2022)
  • K182743 — Patient-Specific Airway Stent (October 23, 2019)
  • K894380 — DUMON TRACHEOBRONCHIAL STENT (October 24, 1989)
  • K873742 — HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES (October 1, 1987)

FDA data resources