Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001556604

FEI Number

3001556604

Entity Name

Novanta Medical GmbH

City/State/Country

BERLIN, DE

Establishment Address

Siemensdamm 58, BERLIN 13627, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K990732

PMA Number

N/A

All Registered Proprietary Names

Da Vinci Insufflator Tube Set - Smoke Evacuation Da Vinci Insufflator IUR FLUID MANAGEMENT SYSTEM GAMMA FINDER III Synergy Insufflation 40 L High Flow Insufflator F108, F107, F104 and F112 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 Insufflator 50L SynergyInsufflation PUMP, FLUID SAFE FLUID MANAGEMENT SYSTEM 2222 Hystero Pump II LAP-Pump PP110 LAP-Pump PP120 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 PNEUMO SURE HIGH FLOW INSUFFLATOR PNEUMO SURE XL HIGH FLOW INSUFFLATOR 45L Core Insufflator F114 AirSeal iFS System CAMERA HEAD AC - C-MOUNT COUPLER AC ZOOM Heated High-Flow Tube Set Smoke Evacuation High-Flow Tube Set High-Flow Tube Set Heated Humidified Smoke Evacuation Tube Set Pneumoclear GoFlo Pump A127 Pump for Arthroscopy A127 FloSteady Flosimple Arthroscopy Pump A120 and A119 Irrigation Pump Unit AQL-100PBS Multiple Fluid Monitoriing Unit AQL-100CBS AQUILEX FLUID CONTROL SYSTEM AQL-100S Lap Wave 3000, P07 and P101

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2024-03-18
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2012-09-17
IZD	Probe, Uptake, Nuclear	Radiology	Class 1	892.1320	2004-04-07
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
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2008-03-06
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-12-16
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	2008-03-06
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	2018-04-12
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2018-04-12
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2008-03-06
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
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2018-10-18
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
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-03-06
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2018-02-07
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2008-03-06

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
8043980	Novanta Medical GmbH	LUDWIGSSTADT Bavaria, 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
K905706	Circon Acmi	GYN-1500 HYSTEROSCOPIC INUFFLATOR	1991-02-28
K942580	Neoprobe Corp.	NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES	1995-02-09
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
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.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

Similar Registrations

Registration Number	Establishment Name	Location
1057358	RG Medical USA	Mount Juliet, TN, US
1225798	ATC TECHNOLOGIES INC.	Wilmington, MA, US
9610612	AESCULAP AG	TUTTLINGEN, DONAU Baden-Wurttemberg, DE
1320894	CONMED CORPORATION	Utica, NY, US
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001556604. Last updated year: 2026. Please use registration number 3001556604 when referencing this establishment in official correspondence.