Arvato SE

FDA Device Registration & Listing · Hamburg, DE · Registration 3013247477

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013247477
FEI Number
3013247477
Entity Name
Arvato SE
City/State/Country
Hamburg, DE
Establishment Address
Werner-Schroeder Str 1, Hamburg 21035, DE
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Arvato SE (Owner Number: 10053073)
Owner / Operator Contact Address
Werner-Schroeder Str 1, Hamburg, DE-HH 21035, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Knife Scalpel handle Ear knife Incision knife Round knife Adenotome Roller knife Tonsil knife Swivel knife Dissector Lancet knife Laryngeal knife Sickle knife Scissors Biopsy forceps Grasping forceps Hook Knot pusher Needle Introducer Pick Tracheal hook Ear hook Superview Laparoscope System for General Surgery MAPC Probes ONE PIECE SIDE EFFECT ELECTRODE CoolPulse 90 Electrode with Hand Controls MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE Disposable Lap. Instruments HF Resection Electrode Loop with Runner GVAP ELECTRODE (5 PACK) (VRS RESECTOSCOPE ELECTRODE) Jar, stainless steel Glass tray LAPAROSCOPIC SCISSORS INNER SHEATH (RESECTOSCOPE SHEATH, INNER - 24 Fr. Electrosurgical Generator ESG-410 and Accessories Roller Electrodes for OB/Gyn HI-Q HAND INSTRUMENTS, OB/GYN USE OLYMPUS BIPOLAR FORCEPS AND ACCESSORIES PK Superpulse System Generator Model 744000 HF-cables (reusable) Suction tube Septum cannula Cannula Mandrin, for Suction tubes Ureteroscopes, flexible and rigid, light source, video processor LARYNGOSTROBOSCOPE LIGHT SOURCE FOR STROBOSCOPY Septum needle Suction tube Bipolar Applicator CELON ProCurve V Cleaning Accessory Electrode, Fine Needle Gyrus G3 Generator Mediastinoscope Hysteroscopes, forceps VAPR COOLPULSE Curve Suction Electrode PK Button OLYMPUS STERILIZATION TRAYS Olympus KeyMed Instrument Tray Tube set Flexible Tipe Thoraroscope Trocar Mallet WB990310; WB990311; WB990210;WB990211 Teeth protector Spatula Tongue depressor Light carrier, fiber optic Throat microphone Light source Tray HF Resection Electrodes Loop Ear loop Ear curette Polyp snare Noise apparatus Tuning fork Rule Probe Measuring instrument Plastic Surgery System Instrument tray, for semi-rigid ureteroscope Resection Sheath for Hysteroscopy Instrument basket, for EndoEYE Sinuscope VAPR TC ELECTRODE GVAP ELECTRODE (5 PACK) (VRS RESECTOSCOPE ELECTRODE) GVAP LOOP ELECTRODE (5 PACK) (VRS ANGLED LOOP RESECTOSCOPE ELECTRODE) GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE Suction Coagulator PK PLASMA-V INSTRUMENT Choledochoscope, flexible and rigid Gyrus Plasma Sect Urology Telescope "V-DOV" Gyrus Plasma V; Gyrus Urology Kit; Plasma Cise; Plasma Cut CLL-V1 LED Light Source Elevator Suction elevator Retractor and accessories Semi-rigid scissors Saw Raspatory Scoring instrument Cartilage crusher Rasp Resection Sheath for Urology ESG-100 AFU-100 HYSTEROSCOPIC BRIDGE (VISUAL OBTURATOR) ROTATABLE OUTER SHEATH Electrosurgical Generator ESG-150 Syringe Micro-biopsy forceps Grasping forceps Artery forceps Dissection forceps Tonsil forceps VICROSAFE 6 AND VICROSAFE 12 Rigid and percutaneous nephroscope Disposable Electrosurgical Pencil Ultra telescopes VAPR ARCTIC articulating hip electrode with dome tip Gauge pin Osteotome Gouge Chisel Dilator Versapoint Punch forceps Speculum and accessories PK Generator; PlasmaKinetic System HF-resection electrodes Hysteroscope accessories Light carrier Light clip OLYMPUS RIGID URETERORENOSCOPE Electrosurgical loops Articulated arm and accessories Chest support PENADAPT 10 Head light RD SHORT WEDGE (2.3mm WEDGE (SHORT)) RD STANDARD WEDGE 2.3mm WEDGE Needle, for fascial closure Cogent 1 Cord; Gyrus PK Footswitch Light-guide cable MINI LAPAROSCOPY FOR GENERAL SURGERY ENDOEYE HD II Trocar System; Hasson OES ELITE Cystoscope and Accessories Flexible and rigid ureterotome system Electrosurgical Generator ESG-410 and Accessories PKS BiLL HF Resection electrode, cylinder HF Resection Electrode Loop with runner Kidney bowl Tray Round bowl Medicine cup Rack PK Lap Loop Cutting block Cutting jig OLYMPUS OES LAPAROSCOPY SYSTEM HYF Hysteroscopes and telescopes Tonsil dissector and retractor Dissector Cysto-urethroscopes and forceps Hand perforator Needle Perforator Tonsil needle Knife Versapoint Thorascoscope system Arthroscopes, CLV-S20 light source PK Cord; PK generator; SuperLoop; SuperPulse generator; SuperSect Disposable Bipolar Forceps Cable G400 Workstation HYSTEROSCOPY PUMP Monopolar single-use HF cable Head band Clip applier Laryngeal forceps Thumb forceps Grasping forceps Swab forceps Gelfoam pressure forceps Biopsy forceps Adenoid forceps Nasal forceps Punch forceps Turbinate forceps Septum forceps Needle holder Towel forceps Pharyngeal forceps Cotton applicator Ear forceps Dressing forceps Tonsil forceps Electrode, Blade PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM OES Elite Ureteroscopes and Accessories RD END ELECTRODE (2.3 VAPR END EFFECT) Neutral electrode cable SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND Steritray XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT RD SIDE ELECTRODE (2.3 VAPR SIDE EFFECT) Telescope "IR" Telescope "ULTRA" EndoLED Light Source Dermabrader Burr Bone rongeur Leakage Tester Adapter Cleaning Accessories Light-guide Adapter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-30
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2016-11-30
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2016-11-29
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
HRX Arthroscope Orthopedic Class 2 888.1100 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2016-11-29
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-01-08
HFG Coagulator, Laparoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2020-01-08
MMO Tray, Surgical, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-11-29
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-01-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-09-28
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2016-11-29
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-01-31
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-29
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2016-11-29
EQL Laryngostroboscope Ear, Nose, Throat Class 1 874.4750 2016-11-29
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2020-01-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-29
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2022-08-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
EWY Mediastinoscope, Surgical Ear, Nose, Throat Class 2 874.4720 2020-01-08
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2020-01-08
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-11-29
DQI Withdrawal/Infusion Pump Cardiovascular Class 2 870.1800 2016-11-29
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2020-01-08
KTE Trocar, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-30
HXL Mallet General, Plastic Surgery Class 1 878.4800 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-09-29
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2016-11-29
EQH Source, Carrier, Fiberoptic Light Ear, Nose, Throat Class 1 874.4350 2016-11-29
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-11-29
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2016-11-29
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2016-11-30
GWX Fork, Tuning Neurology Class 1 882.1525 2016-11-29
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-11-29
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2022-01-09
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2016-11-29
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2018-05-29
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2020-01-08
HRX Arthroscope Orthopedic Class 2 888.1100 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-01-08
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
FDC Resectoscope, Working Element Gastroenterology, Urology Class 2 876.1500 2020-01-08
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2020-01-08
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2020-01-08
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2020-01-08
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2020-01-08
FDC Resectoscope, Working Element Gastroenterology, Urology Class 2 876.1500 2020-01-08
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2020-01-08
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2020-01-08
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2020-01-08
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2020-01-08
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2016-11-29
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2016-11-29
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-29
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-30
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-01-08
KBC Saw, Nasal Ear, Nose, Throat Class 1 874.4420 2016-11-30
HTR Rasp General, Plastic Surgery Class 1 878.4800 2016-11-29
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-11-29
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2016-11-29
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-11-30
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2018-05-29
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-01-08
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-29
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2020-01-08
FGA Kit, Nephroscope Gastroenterology, Urology Class 2 876.1500 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-10-28
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2016-10-28
NMH Laparoscope And Accessories, Gynecologic, Reprocessed Obstetrics/Gynecology Class 2 884.1720 2016-10-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
JYJ Gauge, Measuring Ear, Nose, Throat Class 1 874.4420 2016-11-29
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2016-11-29
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2016-11-30
HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4150 2020-01-08
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-01-08
KTF Punch, Ent Ear, Nose, Throat Class 1 874.4420 2016-11-30
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-05-29
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2018-05-29
NWW Hysteroscope Accessories Obstetrics/Gynecology Class 1 884.1690 2016-11-30
MQW Transilluminator, Fiber Optic Ear, Nose, Throat Class 1 874.4350 2020-01-09
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2016-11-29
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2016-11-29
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2016-11-30
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2020-01-08
EBA Light, Surgical Headlight Dental Class 1 872.4630 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2020-01-08
HBI Illuminator, Fiberoptic, Surgical Field General, Plastic Surgery Class 2 878.4580 2016-11-29
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-11-29
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2025-07-14
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2025-07-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-07-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-11-29
FGA Kit, Nephroscope Gastroenterology, Urology Class 2 876.1500 2026-06-01
GCP Endoscope, Ac-Powered And Accessories Gastroenterology, Urology Class 2 876.1500 2026-06-01
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-06-01
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-06-01
EZO Urethrotome Gastroenterology, Urology Class 2 876.4770 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-01-09
HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4150 2020-01-08
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2016-11-29
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2016-11-29
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2016-11-29
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2016-11-29
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2016-11-30
HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4150 2016-11-29
NNR Block, Cutting, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2016-11-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-11-29
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2016-11-29
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2016-11-30
GCP Endoscope, Ac-Powered And Accessories Gastroenterology, Urology Class 2 876.1500 2016-11-29
JYS Perforator, Ear-Lobe Ear, Nose, Throat Class 1 874.4420 2016-11-29
HFI Coagulator, Culdoscopic (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2020-01-08
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-01-08
EWY Mediastinoscope, Surgical Ear, Nose, Throat Class 2 874.4720 2016-11-29
HRX Arthroscope Orthopedic Class 2 888.1100 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-29
HKF Mirror, Headband, Ophthalmic Ophthalmic Class 1 886.1500 2016-11-29
HTD Forceps General, Plastic Surgery Class 1 878.4800 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2020-01-08
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2020-09-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-11-29
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2016-11-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-08
HRX Arthroscope Orthopedic Class 2 888.1100 2020-01-08
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2020-09-02
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-09-02
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2020-09-02
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2020-09-02
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2020-09-02
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2016-11-29
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2016-11-29
KBB Rongeur, Nasal Ear, Nose, Throat Class 1 874.4420 2016-11-30
FFY Adaptor, Bulbs, Miscellaneous, For Endoscope Gastroenterology, Urology Class 1 876.1500 2016-11-29

Official Correspondent

Carsten Thiemt

US Agent Details

Todd Brill Business: Gyrus ACMI, Inc. Email: todd.brill@olympus.com Phone: (508) 2077661

Related Public Records

Same Entity

Arvato SE
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013247477. Last updated year: 2026. Please use registration number 3013247477 when referencing this establishment in official correspondence.
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