Data / Medical devices / Germany / Arvato SE
Arvato SE: FDA-registered device maker in Hamburg, Germany, 135 510(k) clearances
Arvato SE is registered with the FDA (registration 3013247477) in Hamburg, Germany. It lists 95 device types. The FDA files 135 510(k) clearances under its listings, the newest dated May 21, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013247477
- Address
- Werner-Schroeder Str 1, Hamburg, Germany, 21035
- Owner or operator
- Arvato SE (10053073)
- Roles
- Repackager or relabeler
- First device listed
- October 28, 2016
- Registered through
- 2026
- Brand names listed
- Adapter, Adenoid forceps, Adenotome, Artery forceps, Arthroscopes, CLV-S20 light source, Articulated arm and accessories, BALL ELECTRODE (5 PACK), Bandage scissors and more
Devices it lists
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. Newest 100 of 135.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 21, 2026 | K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, | FAJ | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 23, 2025 | K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| August 18, 2023 | K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| January 19, 2023 | K221522 | HF-cables (resusable) | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| December 22, 2021 | K213207 | Sheath, Stopcock Accessory | HIH | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 15, 2021 | K203492 | Instrument tray, for semi-rigid ureteroscope | KCT | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| August 3, 2021 | K210651 | Resection Electrodes with HF cable | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| July 30, 2021 | K200770 | Mini PCNL-System | FED | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
| May 17, 2021 | K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 28, 2021 | K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| August 28, 2020 | K200369 | OES Elite Ureteroscopes and Accessories | FGB | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| July 17, 2020 | K200542 | Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head | OWN | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| April 3, 2020 | K193026 | Visera Elite II Video System Center, Visera Elite II Endoeye 3D | GCJ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| August 29, 2019 | K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | HET | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| November 29, 2018 | K182587 | Device Electrosurgical Generator ESG-150 | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 26, 2018 | K180200 | ESG-300, APU-300, Pressure Reducer, MAPC Probes | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 2, 2018 | K171692 | Instrument basket, for EndoEYE | KCT | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| February 15, 2018 | K173877 | BOWA Neutral Electrodes | GEI | Substantially Equivalent | Bowa-Electronics GmbH & Co. KG | accessdata.fda.gov |
| November 16, 2017 | K172535 | Bipolar applicator CELON ProCurve V | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 28, 2017 | K171965 | Resection Electrodes with HF cable | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 9, 2016 | K153701 | ULYSS Multi View Sinuscope | EOB | Substantially Equivalent | Sopro-Comeg GmbH | accessdata.fda.gov |
| September 6, 2016 | K161600 | Resection Electrodes | JOS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| May 6, 2016 | K160053 | Monopolar single-use HF cable | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| May 4, 2016 | K160639 | Electrosurgical Generator ESG-200 | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 21, 2016 | K160249 | ULTRA Telescopes | HRX | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 21, 2016 | K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting System | GEI | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| April 5, 2016 | K153009 | ULTRA Telescopes | EOB | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| November 24, 2015 | K151191 | OES ELITE Telescopes, Protective Tube | FBP | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| October 26, 2015 | K152092 | Resection Electrodes | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 29, 2015 | K150633 | ULTRA Telescopes | GCJ | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 3, 2015 | K143475 | VAPR Tripolar Suction Electrode | GEI | Substantially Equivalent | Depuy Mitek | accessdata.fda.gov |
| January 27, 2015 | K142249 | SCHOELLY SINUSCOPE | EOB | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| December 10, 2014 | K140624 | HICURA HAND INSTRUMENTS | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| November 21, 2014 | K142525 | PK Lap Loop | HIN | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| August 5, 2014 | K140896 | VAPR ARCTIC SUCTION ELECTRODE | GEI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| July 30, 2014 | K133311 | ENDOLED | NTN | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| March 3, 2014 | K131402 | VISICLEAR SMOKE EVACUATION SYSTEM | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| June 19, 2013 | K130819 | CLL- V1 LIGHT SOURCE | NTN | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 22, 2013 | K122167 | NEXXIS OR | DXJ | Substantially Equivalent | Barco N.V. | accessdata.fda.gov |
| April 4, 2013 | K123732 | HYSTEROSCOPY PUMP HM6 | HIG | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| December 5, 2012 | K122605 | PKS BILL | HIN | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| November 5, 2012 | K122425 | VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT | GEI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| June 20, 2012 | K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 6, 2012 | K120095 | SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND | GEI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| February 27, 2012 | K113545 | VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN | GEI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| February 15, 2012 | K110748 | OLYMPUS INSTRUMENT TRAY | KCT | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| January 20, 2012 | K111202 | SURGICAL TISSUE MANAGEMENT SYSTEM | GEI | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 2, 2011 | K111751 | VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS | HIN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 25, 2011 | K111342 | LIGHT GUIDE CABLE | HBI | Substantially Equivalent | Schott North America | accessdata.fda.gov |
| January 11, 2011 | K102781 | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| July 1, 2010 | K100816 | PK SUPERPULSE SYSEM GENERATOR MODEL 744000 | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| July 1, 2010 | K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| June 18, 2010 | K100638 | VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 | GEI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| February 24, 2010 | K093181 | GYRUS ACMI PK BUTTON ELECTRODE | FAS | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| June 29, 2009 | K090980 | HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L | NWB | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| December 19, 2008 | K082643 | 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE | GEI | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| August 6, 2008 | K082054 | GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| May 8, 2008 | K073207 | OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 | GEI | Substantially Equivalent | Celon AG Medical Instruments | accessdata.fda.gov |
| May 2, 2008 | K080093 | PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| December 1, 2006 | K063485 | LOGIC LAPAROSCOPIC SCISSORS | GEI | Substantially Equivalent | Surgical Innovations Plc | accessdata.fda.gov |
| November 9, 2005 | K050550 | GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | Gyrus Medical, Inc. | accessdata.fda.gov |
| July 8, 2005 | K050502 | SINGLE USE BALLOON DILATOR MAXPASSTM | FGE | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 10, 2004 | K041285 | GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | GEI | Substantially Equivalent | Gyrus Medical , Ltd. | accessdata.fda.gov |
| August 2, 2004 | K033222 | OLYMPUS STERILIZATION TRAYS | KCT | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| May 10, 2004 | K041135 | VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES | HRX | Substantially Equivalent | Depuy Mitek, A Johnson & Johnson Company | accessdata.fda.gov |
| March 9, 2004 | K040302 | VERSAPOINT RESECTOSCOPIC SYSTEM | HIH | Substantially Equivalent | Gynecare, A Div. of Ethicon, Inc. | accessdata.fda.gov |
| January 30, 2004 | K033651 | OLYMPUS VIDEO URETEROSCOPE, NTSC | FGB | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 26, 2003 | K032838 | CELON ENT SYSTEM | GEI | Substantially Equivalent | Celon AG Medical Instruments | accessdata.fda.gov |
| July 21, 2003 | K031085 | GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) | GEI | Substantially Equivalent | Gyrus Medical, Inc. | accessdata.fda.gov |
| April 10, 2003 | K022449 | HYSTEREOSCOPY PUMP HM4 | HIG | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| March 24, 2003 | K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT | KNS | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| October 8, 2002 | K020507 | OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 | GWG | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 4, 2002 | K020067 | GYRUS ENT SOMNOPLASTY GENERATOR | GEI | Substantially Equivalent | Gyrus Ent LLC | accessdata.fda.gov |
| December 19, 2000 | K003569 | PLASMAKINETIC ENDOUROLOGY SYSTEM | KNS | Substantially Equivalent | Gyrus Medical , Ltd. | accessdata.fda.gov |
| October 31, 2000 | K003060 | PLASMAKINETIC GENERATOR | GEI | Substantially Equivalent | Everest Medical Corp. | accessdata.fda.gov |
| August 31, 2000 | K002422 | VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM | GEI | Substantially Equivalent | Mitek Products | accessdata.fda.gov |
| August 31, 2000 | K002402 | VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM | HRX | Substantially Equivalent | Mitek Products | accessdata.fda.gov |
| June 8, 2000 | K000904 | PENADAPT 10 | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| April 28, 2000 | K001270 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE | FJL | Substantially Equivalent | Gyrus Medical , Ltd. | accessdata.fda.gov |
| April 19, 2000 | K000936 | VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM | GEI | Substantially Equivalent | Mitek Products | accessdata.fda.gov |
| March 30, 2000 | K993041 | OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT | FAJ | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| January 24, 2000 | K994418 | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) | HIH | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| January 18, 2000 | K992901 | GYNECARE VERSAPOINT G-VAP ELECTRODE | HIH | Substantially Equivalent | Gynecare, Inc. | accessdata.fda.gov |
| December 27, 1999 | K994166 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE | KNS | Substantially Equivalent | Gyrus Medical , Ltd. | accessdata.fda.gov |
| December 3, 1999 | K993749 | GYRUS HYSTEROSCOPIC RESECTOSCOPE | HIH | Substantially Equivalent | Gyrus Medical , Ltd. | accessdata.fda.gov |
| September 29, 1999 | K992141 | OLYMPUS WORKING ELEMENT FOR PROBES | FDC | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 24, 1999 | K992876 | VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM | HRX | Substantially Equivalent | Mitek Products | accessdata.fda.gov |
| August 6, 1999 | K992406 | VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM | GEI | Substantially Equivalent | Mitek Products | accessdata.fda.gov |
| July 12, 1999 | K990237 | TROCAR SYSTEM ACCORDING TO HASSON | GCJ | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| June 29, 1999 | K990628 | GYRUS ENDOUROLOGY SYSTEM | KNS | Substantially Equivalent | Gyrus Medical , Ltd. | accessdata.fda.gov |
| March 1, 1999 | K982738 | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) | HIH | Substantially Equivalent | Gynecare, Inc. | accessdata.fda.gov |
| February 24, 1999 | K984417 | BIPOLAR GRASPING FORCEPS BIQ+ | GEI | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| January 21, 1999 | K982771 | GYRUS HYSTEROSCOPIC RESECTOSCOPE | HIH | Substantially Equivalent | Gyrus Medical , Ltd. | accessdata.fda.gov |
| December 24, 1998 | K983811 | UNIPOLAR OPTICAL BIOPSY FORCEPS | KGE | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| January 12, 1998 | K974022 | VAPR | GEI | Substantially Equivalent | Mitek Products | accessdata.fda.gov |
| August 27, 1997 | K971166 | OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE | EWY | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| March 6, 1997 | K954488 | ROLLER ELECTRODE | HIH | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| December 20, 1996 | K962474 | OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) | FBO | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| November 25, 1996 | K963783 | MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE | GEI | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 1, 1996 | K962482 | SCUBA SYSTEM | HIH | Substantially Equivalent | Gynecare, Inc. | accessdata.fda.gov |
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Updated May 21, 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.