510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K971509Substantially Equivalent - Subject to Tracking Reg.

Endoxane

Novatech S.A., Aubagne, FR / Traditional, Substantially Equivalent - Subject to Tracking Reg.
FDA source (opens on fda.gov)

K971509 is the FDA 510(k) clearance record for ENDOXANE, a class II device, cleared for Novatech SA on under FDA product code NWA (Prosthesis, Tracheal, Preformed/Molded). FDA's definition for product code NWA reads: "The device is intended to provide support to weakened or constricting airway walls". FDA records list 5 510(k) clearances for Novatech SA, from to . As of , FDA records show no recalls naming K971509.

Clearance record

Decision date
Received
(118 days to decision)
Product code
NWA Prosthesis, Tracheal, Preformed/Molded
Regulation
21 CFR 878.3720
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Novatech SA Ave. Du Vent Des Dames, Aubagne, FR
Third party review
No

Clearances, product code NWA

Trailing 12 months
1 clearance under product code NWA in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NWA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260