Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613846

FEI Number

3002807769

Entity Name

NOVATECH S.A.

City/State/Country

LA CIOTAT CEDEX Bouches-du-Rhone, FR

Establishment Address

1058, VOIE ANTIOPE, ZI ATHELIA 3, LA CIOTAT CEDEX Bouches-du-Rhone 13705, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NOVATECH SA (Owner Number: 9011747)

Owner / Operator Contact Address

VOIE ANTIOPE, ZI ATHELIA 3, LA CIOTAT CEDEX, FR-NOTA 13705, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242324

PMA Number

N/A

All Registered Proprietary Names

TRACHEOBRONXANE-DUMON STENTS TalcAir Application System SURVAC DUTAU NOVATECH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NWA	Prosthesis, Tracheal, Preformed/Molded	General, Plastic Surgery	Class 2	878.3720	1994-10-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-01-22
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2024-06-13
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-02-11

Official Correspondent

Marcus Eisenhut

US Agent Details

Stuart Montgomery Business: Boston Medical Products, Inc. Email: regulatory@bosmed.com Phone: (508) 8989300

Related Public Records

Same Entity

NOVATECH SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

Similar Registrations

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3016804805	CLEARCAM	Austin, TX, US
3011936016	Sony Olympus Medical Solutions Inc.	Hachioji-shi Tokyo, JP
3015335150	VERNACARE LTD.	Chorley Lancashire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613846. Last updated year: 2026. Please use registration number 9613846 when referencing this establishment in official correspondence.