Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033043422

FEI Number

3033043422

Entity Name

NOVANTA MEDICAL S.R.O.

City/State/Country

Prelouc Pardubicky Kraj, CZ

Establishment Address

Pardubicka 1571, Prelouc Pardubicky Kraj 535 01, CZ

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

CAMERA HEAD AC - C-MOUNT COUPLER AC ZOOM PUMP, FLUID SAFE FLUID MANAGEMENT SYSTEM 2222 Hystero Pump II Flocontrol -Arthroscopy Pump Model 150 Arthroscopy Pump A107 and A114 ConductOR ND3, Connect OR ScaleOR ExpandOR HysteroFlow II / HysteroBalance II PNEUMO SURE HIGH FLOW INSUFFLATOR PNEUMO SURE XL HIGH FLOW INSUFFLATOR 45L Core Insufflator F114 Irrigation Pump Unit AQL-100PBS Multiple Fluid Monitoriing Unit AQL-100CBS AQUILEX FLUID CONTROL SYSTEM AQL-100S RADIANCE Vital Screen LifeVue Evolution family ND-Cam ENDOVUE GX5MP Evolution4K ZeroWire or ZeroWire G2 Heated High-Flow Tube Set Smoke Evacuation High-Flow Tube Set High-Flow Tube Set Heated Humidified Smoke Evacuation Tube Set Pneumoclear GAMMA FINDER III IUR FLUID MANAGEMENT SYSTEM high pressure hose for bottle gas supply CO2 gas connectors hoses for central gas supply 1031 Sterile Sleeve, GAMAA FINDER III LAP-Pump PP110 LAP-Pump PP120 Lap Wave 3000, P07 and P101 Autoclavable Fixed Focal Lenght Coupler C-Mount HD Optical Zoom Coupler Autoclavable HD-Zoom Coupler AirSeal iFS System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2018-10-18
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2008-03-06
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-03-06
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2024-09-05
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
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2013-06-13
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2008-03-06
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2018-02-07
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2024-09-11
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2024-09-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-09-05
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
IZD	Probe, Uptake, Nuclear	Radiology	Class 1	892.1320	2004-04-07
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2012-09-17
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2018-01-30
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2024-09-19
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2017-04-05
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2008-03-06
FEI	Instrument, Special Lens, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2015-10-23
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

Official Correspondent

Silke Lucht

US Agent Details

Aylin Ng Saye Business: NOVANTA MEDICAL USA, INC. Email: aylin.ngsaye@novanta.com Phone: (407) 4720369

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
8043980	Novanta Medical GmbH	LUDWIGSSTADT Bavaria, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K940152	Hydro-Med Products, Inc.	CAMERA COVER WITH TEAR TIP	1994-10-28
K905706	Circon Acmi	GYN-1500 HYSTEROSCOPIC INUFFLATOR	1991-02-28
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K981334	Richard Wolf Medical Instruments Corp.	LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)	1998-09-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033043422. Last updated year: 2026. Please use registration number 3033043422 when referencing this establishment in official correspondence.