Data / Medical devices / Germany / Novanta Medical GmbH
Novanta Medical GmbH: FDA-registered device maker in Berlin, Germany, 19 510(k) clearances
Novanta Medical GmbH is registered with the FDA (registration 3001556604) in Berlin, Germany. It lists 11 device types. The FDA files 19 510(k) clearances under its listings, the newest dated August 19, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001556604
- Address
- Siemensdamm 58, Berlin, Germany, 13627
- Owner or operator
- Novanta Medical GmbH (9004880)
- Roles
- Specification developer
- First device listed
- April 7, 2004
- Registered through
- 2026
- Brand names listed
- 2222 Hystero Pump II, 40 L High Flow Insufflator F108, F107, F104 and F112, 45L Core Insufflator F114, AQUILEX FLUID CONTROL SYSTEM AQL-100S, AirSeal iFS System, Arthroscopy Pump A107 and A114, Autoclavable Fixed Focal Lenght Coupler, Autoclavable HD-Zoom Coupler and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | 1 | Specification developer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Special Lens, For Endoscope | FEI | 1 | Specification developer | accessdata.fda.gov |
| Insufflator, Endoscopic Vessel Harvesting | OSV | 2 | Specification developer | accessdata.fda.gov |
| Insufflator, Hysteroscopic | HIG | 2 | Specification developer | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Specification developer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Specification developer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Specification developer | accessdata.fda.gov |
| Probe, Uptake, Nuclear | IZD | 1 | Specification developer | accessdata.fda.gov |
| System, Surgical, Computer Controlled Instrument | NAY | 2 | Specification developer | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 19, 2026 | K260209 | ENDOFLATOR+; Smart Smoke Evacuation | HIF | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| December 5, 2025 | K250795 | PUREVUE FMS | HRX | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| September 22, 2025 | K250388 | ENDOFLATOR + | HIF | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| March 14, 2024 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 20, 2023 | K230239 | AirSeal iFS System; AirSeal dV Solution | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 29, 2020 | K201361 | PNEUMOCLEAR | HIF | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| March 28, 2019 | K190303 | AirSeal | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 28, 2018 | K173489 | GYN-Pump PH304 | HIG | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| February 5, 2018 | K172040 | Aquilex Fluid Control System AQL-100S | HIG | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| March 21, 2017 | K163320 | LAP-Pump PP110 | HET | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| March 4, 2016 | K153513 | Insufflator 50L FM134 | HIF | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| April 4, 2013 | K123732 | HYSTEROSCOPY PUMP HM6 | HIG | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| May 23, 2007 | K063367 | 45L CORE INSUFFLATOR, MODEL F114 | HIF | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| December 14, 2006 | K062380 | FLOSIMPLE ARTHROSCOPY PUMP A120 | HRX | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| February 5, 2004 | K030837 | 40 L HIGH FLOW INSUFFLATOR F108 | HIF | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| August 13, 2003 | K031616 | IUR FLUID MANAGEMENT SYSTEM | HIG | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| April 17, 2003 | K030402 | ARTHROSCOPY PUMP, MODEL A107 | HRX | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| April 10, 2003 | K022449 | HYSTEREOSCOPY PUMP HM4 | HIG | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| July 23, 1999 | K990732 | LAP-WAVE 3000 (P07) | HET | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 18, 2021 | 88426 | Class II | Ongoing | Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000 | When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reachin | accessdata.fda.gov |
| August 14, 2019 | 83712 | Class II | Terminated | Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies. | The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk. | accessdata.fda.gov |
| October 22, 2018 | 81480 | Class II | Terminated | PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR | It is possible that the packaging of the product can be damaged by the prongs on the tube set. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Special Lens, For Endoscope
- All makers of Laparoscope, Gynecologic (And Accessories)
- All makers of Insufflator, Laparoscopic
- All makers of Insufflator, Endoscopic Vessel Harvesting
- All makers of Insufflator, Hysteroscopic
- All makers of Tubing/Tubing With Filter, Insufflation, Laparoscopic
Updated August 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.