Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680515

FEI Number

3005969827

Entity Name

TONTARRA MEDIZINTECHNIK GMBH

City/State/Country

WURMLINGEN Baden-Wurttemberg, DE

Establishment Address

DAIMLERSTRASSE 15, WURMLINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TONTARRA MEDIZINTECHNIK GMBH (Owner Number: 9009570)

Owner / Operator Contact Address

DAIMLERSTRASSE 15, --, WURMLINGEN, DE-BW D-78573, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CANNULA, SURGICAL DENTAL FORCEPS Laparoscopic Instruments Kerrison Rongeur Tenaculum Forceps 20-0406 Endoscopes and Accessories Liver Retractor Uterusmanitpulator Osteotome CREED Extraction Kit Osteotome - F5-1011-000 Forceps Instruments, Surgical, Cardiovascular Mc Pherson Scissors Vannas Scissors Multifunctional trocar sleeve Pliers, operative SURGICAL TOOTH EXTRACTOR FORCEPS MANUAL SURGICAL GENERAL USE INSTRUMENT Electrosurgical Instruments & Accessories KNIFE SURGICAL Suction Tube Periodontic Scaler Rongeur MiniFESS Suction Hammer, Surgical Powergrip Bipolar Coagulation Forceps Detachable Bipolar Forceps Plier File, Bone, Surgical Mako Shoulder Application ASTS-000204 ASTS-000209 ASTS-000205 ASTS-000207 ASTS-000208 ASTS-000210 Osteotomes ENDOSCOPIC COAGULATOR-CUTTER HOOK SURGICAL, GENERAL PLASTIC SURGERY OSTRUM antrum punch MCKENTY PUNCH DISSECTING SCISSORS SCOOP Alar Retraktor X6205 SCISSORS GENERAL SURGICAL CUTTER SURGICAL LAPAROSCOPIC ACCESSORIES Forceps BIOPSY FORCEPS, GYNECOLOGICAL Thoracic Forceps and Clamps INSTRUMENT, MANUAL, GENERAL OBSTETRIC-GYNECOLOGIC SELF-RETAINING RETRACTORS Rongeur Nasal SCISSORS, NASAL TONSIL SCISSORS STEEL RULER SURGICAL CLAMPS Fixed Size Cervical Dilators, SURGICAL PUNCH VERES cannula CHISEL SURGICAL Bone Forceps Sphenoid punch NEEDLE SUTURING REUSABLE SUCTION TUBE SUCTION IRRIGATION TUBE Elevator, Surgical, Dental MICRO NEEDLE HOLDERS BIB Removal Instruments ASTS-000207 ASTS-000205 SD2-341040 ASTS-000204 SD2-271000 ASTS-000206 DEVILBISS RONQEUR 70-1865CWP 70-1862CWP 70-1864CWP 70-1863CWP 70-1851CWP PERIODONTIC PROBE NON-ELECTRIC FORCEPS BIOPSY Castroviejo Caliper BIT DRILL Explorer, Operative MICROSURGICAL INSTRUMENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2002-05-20
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2018-12-20
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1994-02-08
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2018-08-22
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2002-05-20
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2012-11-14
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2016-09-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-10-31
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2010-05-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-06-05
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2018-10-22
EMR	File, Periodontic	Dental	Class 1	872.4565	2022-10-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-10-07
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-30
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2016-11-21
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2012-11-09
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2023-05-05
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2002-05-20
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2014-01-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-08-07
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-11-14
FBQ	Trocar, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5090	2008-05-12
BWB	Forceps, Tube Introduction	Anesthesiology	Class 1	868.5780	2016-12-07
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2018-11-12
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2012-11-14
EJY	Pliers, Operative	Dental	Class 1	872.4565	2002-05-20
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2002-05-21
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2002-05-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-10-07
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2002-05-20
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2012-10-31
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2012-11-14
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2002-05-20
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2021-12-21
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2002-05-20
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2019-04-24
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2022-08-23
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2016-04-22
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2016-04-22
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2016-04-22
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-08-26
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2012-02-10
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2012-02-10
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2012-02-10
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2012-02-10
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2019-10-10
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2012-12-18
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2016-06-01
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-05-26
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2020-09-24
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2007-06-15
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2002-05-20
KTF	Punch, Ent	Ear, Nose, Throat	Class 1	874.4420	2021-06-17
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2018-08-22
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2018-10-25
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2002-05-20
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2014-05-23
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	2002-05-20
FNS	Ring Cutter	General Hospital	Class 1	880.6200	2018-08-22
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	1997-11-10
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2018-08-22
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-11-14
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2002-05-20
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2002-05-20
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2018-08-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-06-15
HXW	Bender	Orthopedic	Class 1	888.4540	2013-02-15
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-06-05
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2009-08-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-11-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-11
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2002-05-21
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2017-10-12
FAX	Bougie, Urological	Gastroenterology, Urology	Class 1	876.5520	2016-03-10
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2007-07-31
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2012-11-09
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2018-10-26
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	1997-11-10
KBM	Dissector, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2007-07-31
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2007-11-28
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2002-05-20
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2010-02-12
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2018-10-25
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2002-05-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-09-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-09-17
FHR	Needle, Gastro-Urology	General, Plastic Surgery	Class 1	878.4800	2022-08-22
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2002-05-20
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2012-09-06
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2018-12-05
KBS	Punch, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2024-12-13
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	2002-05-20
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2010-05-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-08-22
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2012-12-18
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2007-07-31
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2018-08-24
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2012-11-14
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2009-01-13
HTX	Rongeur	Orthopedic	Class 1	888.4540	1994-02-08
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2002-05-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2016-04-22
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2002-05-20
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-11-09
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2016-04-22
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2002-05-21
EKB	Explorer, Operative	Dental	Class 1	872.4565	2012-12-18
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2002-05-21
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2023-05-04

Official Correspondent

Andreas Birk

US Agent Details

Angelika Scherp Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

TONTARRA MEDIZINTECHNIK 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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K936071	Smith & Nephew Dyonics, Inc.	SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE	1994-08-19
K953574	American Hydro-Surgical Instruments, Inc.	NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER	1995-09-29
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680515. Last updated year: 2026. Please use registration number 9680515 when referencing this establishment in official correspondence.