Cleared Traditional

ENDOXANE

K971509 · Novatech SA · General & Plastic Surgery
Aug 1997
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K971509 is an FDA 510(k) clearance for the ENDOXANE, a Prosthesis, Tracheal, Preformed/molded (Class II — Special Controls, product code NWA), submitted by Novatech SA (Aubagne, FR). The FDA issued a Cleared decision on August 21, 1997, 118 days after receiving the submission on April 25, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3720.

Submission Details

510(k) Number K971509 FDA.gov
FDA Decision Cleared ST
Date Received April 25, 1997
Decision Date August 21, 1997
Days to Decision 118 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code NWA — Prosthesis, Tracheal, Preformed/molded
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3720
Definition The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls.