Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611503

FEI Number

3002808335

Entity Name

TEKNO MEDICAL OPTIK-CHIRURGIE GMBH

City/State/Country

TUTTLINGEN-Nendingen Baden-Wurttemberg, DE

Establishment Address

SATTLERSTRASSE 11, TUTTLINGEN-Nendingen Baden-Wurttemberg 78532, DE

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

TEKNO-MEDICAL OPTIK-CHIRURGIE GMBH (Owner Number: 10027774)

Owner / Operator Contact Address

Sattlerstrasse 11, Tuttlingen, DE-BW 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Head Mirror VISUAL OBTURATOR FOR HYBRID RESECTOSCOPE Atria 1 (LED, Single Color) Atria 2 (LED, Single Color) Atria 3 (LED, Single Color) Atria 2 (LED, Single Color) Atria 5 (LED, Single- / Multicolor) Atria 7 (LED, Single- / Multicolor) Atria 3 (LED, Single Color) Atria 1 (LED, Single Color) Atria 3 (LED, Single Color) Atria 1 (LED, Single Color) Atria 5 (LED, Single- / Multicolor) Atria 7 (LED, Single- / Multicolor) Atria 2 (LED, Single Color)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2008-12-02
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	2017-10-25
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2008-12-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-09
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-12-02
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-12-02
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2025-01-16
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-01-16
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2008-12-02
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-12-02
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2013-05-22
EAJ	Apron, Leaded	Radiology	Class 1	892.6500	2008-12-02
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-02-09
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2011-03-15
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2016-09-20
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2008-12-02
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	2008-12-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-06-09
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2008-12-02
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2009-11-12
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2008-12-02
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2010-03-29
GCT	Light Source, Endoscope, Xenon Arc	Gastroenterology, Urology	Class 2	876.1500	2015-02-06
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2008-12-02
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-12-01
FHM	Apparatus, Suturing, Stomach And Intestinal	General, Plastic Surgery	Class 1	878.4800	2010-06-23
GAI	Stripper, Vein, Reusable	General, Plastic Surgery	Class 1	878.4800	2008-12-02
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2008-12-02
KCC	Bistoury, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2008-12-02
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2008-12-02
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2008-12-02
EIG	Retractor, All Types	Dental	Class 1	872.4565	2013-01-30
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-12-02
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2008-12-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-09
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2008-12-02
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-12-02
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2008-12-02
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-12-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-09
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-04-30
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2008-12-02
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2008-12-02
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2016-06-09
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2016-06-09
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-12-02
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-12-02
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2008-12-02
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2008-12-02
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2008-12-02
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2010-03-01
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2008-12-02
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2008-12-02
EWY	Mediastinoscope, Surgical	Ear, Nose, Throat	Class 2	874.4720	2015-01-30
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2025-03-20
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2025-03-20
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-03-20
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2008-12-04
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2010-04-23
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2008-12-02
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2008-12-02
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2008-12-02
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2008-12-02
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2008-12-02
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2008-12-02
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2015-01-29
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-12-02
EKB	Explorer, Operative	Dental	Class 1	872.4565	2014-08-20
FHK	Spreader, Bladder Neck	Gastroenterology, Urology	Class 1	876.4730	2008-12-02
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2008-12-02
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2008-12-02
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2008-12-02
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2008-12-02
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-12-02
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2008-12-02
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2010-03-19
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2008-12-02
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2008-12-02
KAC	Tube, Laryngectomy	Ear, Nose, Throat	Class 1	874.4420	2018-04-17
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2008-12-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-12-02
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	2008-12-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-09
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2008-12-02
HWB	Extractor	Orthopedic	Class 1	888.4540	2008-12-02
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-12-02
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2008-12-02
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	2010-03-19
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2008-12-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-06-09
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2008-12-02
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	2008-12-02
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-12-02
HTX	Rongeur	Orthopedic	Class 1	888.4540	2008-12-02
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2008-12-02
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2018-12-18
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2008-12-02
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-12-02
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2008-12-02
FQP	Lamp, Operating-Room	General, Plastic Surgery	Class 2	878.4580	2015-02-05
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2008-12-02
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2008-12-02
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2012-04-30
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-12-02
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2008-12-02
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-12-02
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-12-02
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2008-12-02
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2016-06-09
GWY	Pinwheel	Neurology	Class 1	882.1750	2008-12-02
KAW	Punch, Antrum	Ear, Nose, Throat	Class 1	874.4420	2013-07-15
FGO	Dislodger, Stone, Flexible	Gastroenterology, Urology	Class 2	876.4680	2017-01-16
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2008-12-02
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2008-12-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-12-02
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	2008-12-02
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2008-12-02
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2015-02-05
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2008-12-02
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2008-12-02
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2008-12-02
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-06-09
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2008-12-02
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2008-12-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-06-09
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-12-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-02-28
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2025-02-28
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-12-02
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-12-02

Official Correspondent

FLORIAN MATTES

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

TEKNO-MEDICAL OPTIK-CHIRURGIE GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611503. Last updated year: 2026. Please use registration number 9611503 when referencing this establishment in official correspondence.