FDA Registration
Active
🇩🇪 Germany
Arvato SE
Reg #: 3013247477
·
FEI: 3013247477
·
Expires 2026
Products
95
Proprietary Names
276
Establishment Types
1
Classifications
95
Registration Details
- Registration Name
- Arvato SE
- Registration Number
- 3013247477
- FEI Number
- 3013247477
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Werner-Schroeder Str 1
- City
- Hamburg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K942839
Owner / Operator
- Firm Name
- Arvato SE
- Operator Number
- 10053073
- Address
- Werner-Schroeder Str 1
- City
- Hamburg
- State
- DE-HH
- Postal Code
- 21035
- Country
- DE
- Correspondent
- Carsten Thiemt
US Agent
- Business Name
- Gyrus ACMI, Inc.
- Contact Name
- Todd Brill
- Address
- 800 West Park Drive, --
- City
- Westborough
- State
- MA
- ZIP
- 01581
- Country
- US
- [email protected]
- Phone
- 508 2077661
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2016-11-30 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2020-01-08 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-05-29 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2020-01-08 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2016-11-29 |
| Coagulator, Laparoscopic, Unipolar (And Accessories) | HFG | Class 2 | Obstetrics/Gynecology | No | 2020-01-08 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2016-11-29 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2020-01-08 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2016-11-29 |
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2020-01-09 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2022-08-18 |
| Mediastinoscope, Surgical | EWY | Class 2 | Ear, Nose, Throat | No | 2020-01-08 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2020-01-08 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2016-11-29 |
| Withdrawal/Infusion Pump | DQI | Class 2 | Cardiovascular | No | 2016-11-29 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2016-11-29 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2020-01-08 |
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2020-01-08 |
| Resectoscope, Working Element | FDC | Class 2 | Gastroenterology, Urology | No | 2020-01-08 |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | Class 2 | Gastroenterology, Urology | No | 2020-01-08 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2020-01-08 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2020-01-08 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2016-11-29 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2016-11-29 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2016-11-29 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2018-05-29 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2020-01-08 |
| Kit, Nephroscope | FGA | Class 2 | Gastroenterology, Urology | No | 2016-11-29 |
| Laparoscope And Accessories, Gynecologic, Reprocessed | NMH | Class 2 | Obstetrics/Gynecology | No | 2016-10-28 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | Class 2 | Obstetrics/Gynecology | No | 2020-01-08 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Electrode, Electrosurgical | JOS | Class 2 | General, Plastic Surgery | No | 2018-05-29 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2016-11-30 |
| Transilluminator, Fiber Optic | MQW | Class 1 | Ear, Nose, Throat | No | 2020-01-09 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2016-11-29 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Illuminator, Fiberoptic, Surgical Field | HBI | Class 2 | General, Plastic Surgery | No | 2016-11-29 |
| Endoscope, Accessories, Narrow Band Spectrum | NWB | Class 2 | Gastroenterology, Urology | No | 2025-07-14 |
| Endoscope, Ac-Powered And Accessories | GCP | Class 2 | Gastroenterology, Urology | No | 2026-06-01 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2026-06-01 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2016-11-29 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2016-11-30 |
| Block, Cutting, Ent, Non-Sterile | NNR | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Perforator, Ear-Lobe | JYS | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Coagulator, Culdoscopic (And Accessories) | HFI | Class 2 | Obstetrics/Gynecology | No | 2020-01-08 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2016-11-29 |
| Mirror, Headband, Ophthalmic | HKF | Class 1 | Ophthalmic | No | 2016-11-29 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2020-09-02 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2020-09-02 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2016-11-29 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2016-11-30 |
| Urethroscope | FGC | Class 2 | Gastroenterology, Urology | No | 2016-11-29 |
| Telescope, Rigid, Endoscopic | FBP | Class 2 | Gastroenterology, Urology | No | 2016-11-29 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2016-11-30 |
| Endoscope, Rigid | GCM | Class 2 | Gastroenterology, Urology | No | 2020-05-06 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2016-11-29 |
| Inserter, Myringotomy Tube | JYM | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2020-01-08 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2020-01-09 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2020-01-08 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2016-11-29 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2016-11-30 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2016-11-29 |
| Catheter, Suprapubic (And Accessories) | KOB | Class 2 | Gastroenterology, Urology | No | 2016-11-29 |
| Cystourethroscope | FBO | Class 2 | Gastroenterology, Urology | No | 2020-01-08 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2020-01-08 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2016-11-29 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2022-05-30 |
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
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 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
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
PKS BiLL
HF Resection electrode, cylinder
HF Resection Electrode Loop with runner
Kidney bowl
Round bowl
Medicine cup
Rack
PK Lap Loop
Cutting block
Cutting jig
OLYMPUS OES LAPAROSCOPY SYSTEM
HYF Hysteroscopes and telescopes
Tonsil dissector and retractor
Cysto-urethroscopes and forceps
Hand perforator
Perforator
Tonsil needle
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
Swab forceps
Gelfoam pressure forceps
Adenoid forceps
Nasal forceps
Turbinate forceps
Septum forceps
Needle holder
Towel forceps
Pharyngeal forceps
Cotton applicator
Ear forceps
Dressing 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
Hi-Q Instruments
Bipolar Grasping Forceps BiQ+
Mirror
Head mirror
CoolPulse 90 Electrode without Hand Controls
Tubing
Optical Obturator
Plastic Surgery System hand instruments
ONE PIECE LOW PROFILE SUCTION (LPS) ELECTRODE ONE PIECE S50 PLUS ELECTRODE
VISICLEAR SMOKE EVACUATION SYSTEM
OES ELITE Telescopes, Protective Tube
Disposable Loop Electrodes
Bandage scissors
Ear scissors
Laryngeal scissors
Iris scissors
Ligature scissors
Strabismus scissors
Ethmoid scissors
Wire curring scissors
Nasal scissors
Rhinoplasty scissors
Tonsil scissors
Dissection scissors
Visera Elite II Endoeye 3D
ULTRA Telescopes (Arthroscopes)
CELON ELITE ESG-200
Resection Electrodes With HF Cable
Operation laryngoscope
Inserter, for T-Tubes
Ear forceps, inserter for ventilation tubes
OLYMPUS NASAL AND SINUS ENDOSCOPES
MNA-120 ENC DP AUDIO
Hysteroscopic Sheath
P50 Hand Switching
ULTRA Telescopes (Sinuscopes)
Vide ureteroscope
Sheehy Weapon
Sheehy Flap Knife
Infant resectoscope
ESG-100, AFU-100
Disposable Lap. Electrodes
Resection Electrodes with HF cable
Unipolar Optical Biopsy Forceps
Cystofiberscope and nephrofiberscope
VMC-3
VMC accessories
HF Resection Electrode
Tubing, sterile, for UHI smoke evacuation
Suprapubic flow controller
Grasping Forceps
Neuroscopes
CELON ENT SYSTEM
HiCura Hand Instruments
VERSAPOINT GENERATOR
FOOTSWITCH (SMALL)
BALL ELECTRODE (5 PACK)
SPRING ELECTRODE (5 PACK)
TWIZZLE ELECTRODE (5 PACK)
MAXPASS BILIARY CATHETER
PKS PlasmaSORD
Electrosurgical Generator ESG-400 and Accessories
Mini PCNL-System
LPS electrode; Suction electrode
Working Elements and insert
VAPRFLEX END EFFECT (FLEX END EFFECT)
MCEND0550
OES LAPARO-THORACO VIDEOSCOPE (RIGID)
HD Endoeye
Establishment Types
Repack or Relabel Medical Device