Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002858762

FEI Number

3002858762

Entity Name

SPIGGLE & THEIS MEDIZINTECHNIK GMBH

City/State/Country

OVERATH North Rhine-Westphalia, DE

Establishment Address

Burghof 14, OVERATH North Rhine-Westphalia 51491, DE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SPIGGLE & THEIS MEDIZINTECHNIK GMBH (Owner Number: 9050994)

Owner / Operator Contact Address

Burghof 14, --, OVERATH, DE-NOTA 51491, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nasal splints Depressor, Metal Tongue Surgical Teeth Protector Surgical Laryngoscope Suction Tubes, ENT, Single Use Block, Cutting, ENT, NON-STERILE Forceps, Wire Closure, ENT, Non-Sterile Epistaxis catheter Drape, Robotic, sterile Monitor Drape, sterile Spatula Trocar Spiggle & Theis Mouth gag Punch, ENT Panetti Suction Instruments TubaVent Balloon Dilatation System Osteotome, Manual Rasp Knife, ENT REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL , PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT Otoscope, large picture Hook, microsurgical ear Mallet ENT Dilator SPIGGLE THEIS PVA intranasal tampon Volkmann sharp spoon Scissors, Nasal ENT, Forceps, Scissors, Punches, Hooks, Instruments VoiceInject Injection Needle, Lipo Harvesting Cannula Chisel, middle ear Spiggle Theis Forceps for Laryngology, ENT Ear Scissors Spectacle, Magnifier Pean, Kocher, Crile Artery forceps Loop, wire SPIGGLE THEIS Chisel Spiggle & Theis Retractor, Helms, Preyer, Fisch, Wullstein, Wigand, Perkins etc. Loupe, binocular PVA Tampons Ear ENT Bandages Gauge, Measuring - Reference Instrument Perforator, Fisch Footplate Perforator Probe, ENT Eicken Antrum Canula, Frazier Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EPP	Splint, Nasal	Ear, Nose, Throat	Class 1	874.5800	2017-05-05
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2018-04-12
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2018-04-16
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2017-05-09
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2025-09-10
NNR	Block, Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2018-02-19
NNQ	Forceps, Wire Closure, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2018-02-19
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2002-04-30
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2020-02-27
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-09-11
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2025-05-30
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2025-09-12
KTF	Punch, Ent	Ear, Nose, Throat	Class 1	874.4420	2025-09-11
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2016-07-27
PNZ	Eustachian Tube Balloon Dilation Device	Ear, Nose, Throat	Class 2	874.4180	2023-09-05
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2018-04-05
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2025-09-17
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-04-12
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2018-03-12
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2018-03-12
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2016-08-19
JYL	Hook, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2009-05-25
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2018-02-20
KCF	Dilator, Esophageal, Ent	Ear, Nose, Throat	Class 1	874.4420	2025-12-11
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2017-05-05
JZE	Spoon, Ear	Ear, Nose, Throat	Class 1	874.4420	2025-09-01
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2018-02-19
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2017-05-09
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2020-12-18
JYE	Chisel, Middle-Ear	Ear, Nose, Throat	Class 1	874.4420	2018-02-19
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2009-05-25
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2018-02-19
HKC	Spectacle Microscope, Low-Vision	Ophthalmic	Class 1	886.5540	2018-02-19
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2018-02-19
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2018-02-19
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	2018-04-12
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2018-02-19
HJH	Loupe, Binocular, Low Power	Ophthalmic	Class 1	886.5120	2018-02-19
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2025-05-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2017-05-09
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	2018-02-19
JYS	Perforator, Ear-Lobe	Ear, Nose, Throat	Class 1	874.4420	2018-02-19
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-02-19
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2018-02-19

Official Correspondent

Claudia Winterschladen

US Agent Details

David Rattigan Business: Bryan Medical Inc. Email: drattigan@bryanmedical.net Phone: (513) 2721600

Related Public Records

Same Entity

SPIGGLE & THEIS 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
K171761	Acclarent, Inc.	ACCLARENT AERA Eustachian Tube Balloon Dilation System	2018-01-16
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K914226	E.I. Dupont DE Nemours & Co., Inc.	ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK	1991-11-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002858762. Last updated year: 2026. Please use registration number 3002858762 when referencing this establishment in official correspondence.