Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043980

FEI Number

3002914049

Entity Name

Novanta Medical GmbH

City/State/Country

LUDWIGSSTADT Bavaria, DE

Establishment Address

ALTE POST STR. 11, LUDWIGSSTADT Bavaria D-96337, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Novanta Medical GmbH (Owner Number: 9004880)

Owner / Operator Contact Address

Siemensdamm 58, --, Berlin, DE-BE 13627, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Autoclavable Fixed Focal Lenght Coupler C-Mount HD Optical Zoom Coupler Autoclavable HD-Zoom Coupler Synergy Insufflation 40 L High Flow Insufflator F108, F107, F104 and F112 Heated High-Flow Tube Set Smoke Evacuation High-Flow Tube Set High-Flow Tube Set Heated Humidified Smoke Evacuation Tube Set Pneumoclear ZeroWire or ZeroWire G2 PNEUMO SURE HIGH FLOW INSUFFLATOR PNEUMO SURE XL HIGH FLOW INSUFFLATOR 45L Core Insufflator F114 ConductOR ND3, Connect OR ScaleOR ExpandOR high pressure hose for bottle gas supply CO2 gas connectors hoses for central gas supply Insufflator 50L SynergyInsufflation IUR FLUID MANAGEMENT SYSTEM Evolution4K GAMMA FINDER III Irrigation Pump Unit AQL-100PBS Multiple Fluid Monitoriing Unit AQL-100CBS AQUILEX FLUID CONTROL SYSTEM AQL-100S Tube Set for Vacuum incl. Filter HysteroLux Fluid Management System Scale Tube Set for Suction, single-use HysteroLux Fluid Management System Control Unit Tube Set for Suction (with 2 ports), single-use GYN-Pump PH304 Fluid Monitoring Unit PS304 Tube Set for Irrigation, single-use Lap Wave 3000, P07 and P101 1031 Sterile Sleeve, GAMAA FINDER III LAP-Pump PP110 LAP-Pump PP120 PUREVUE FMS Day use tube set for irrigation, pump part, 10 applications Tube set for suction, 2-lines, single-use Tube set for suction, single-use Tube set for vacuum, incl. filter, 30-day use Double pedal foot switch Autoclavable remote control Tube set for irrigation, single-use Patient tube for irrigation, single-use Tube set inflow 4-Spike adaptor AirSeal iFS System RADIANCE Vital Screen LifeVue Evolution family ND-Cam ENDOVUE GX5MP PUMP, FLUID SAFE FLUID MANAGEMENT SYSTEM 2222 Hystero Pump II Flocontrol -Arthroscopy Pump Model 150 Arthroscopy Pump A107 and A114 HysteroFlow II / HysteroBalance II AirSeal iFS System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FEI	Instrument, Special Lens, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2015-10-23
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2008-03-06
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2020-07-30
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2020-07-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-09-05
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2008-03-06
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2024-09-05
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2018-01-30
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2016-03-08
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2016-03-08
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2012-09-17
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2024-09-11
IZD	Probe, Uptake, Nuclear	Radiology	Class 1	892.1320	2004-04-07
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2018-02-07
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2018-04-12
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2018-04-12
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2008-03-06
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2024-09-19
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2025-09-29
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2025-09-29
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2017-04-05
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-12-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-01-17
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2024-01-17
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2024-09-11
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2008-03-06
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-03-06
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2013-06-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-05-11
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2020-05-11

Official Correspondent

Silke Lucht

US Agent Details

Aylin Ng Saye Business: NOVANTA MEDICAL USA, INC. Email: aylin.ngsaye@novanta.com Phone: (407) 4388810

Related Public Records

Same Entity

Novanta Medical GmbH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3001556604	Novanta Medical GmbH	BERLIN, DE
3033043422	NOVANTA MEDICAL S.R.O.	Prelouc Pardubicky Kraj, CZ

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K981334	Richard Wolf Medical Instruments Corp.	LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)	1998-09-10
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

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-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043980. Last updated year: 2026. Please use registration number 8043980 when referencing this establishment in official correspondence.