Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615004

FEI Number

3001130644

Entity Name

EFINGER INSTRUMENTS GmbH & Co. KG

City/State/Country

SPAICHINGEN Baden-Wurttemberg, DE

Establishment Address

MAX-PLANCK-STRASSE 36, SPAICHINGEN Baden-Wurttemberg D-78549, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EFINGER INSTRUMENTS GMBH & Co. KG (Owner Number: 9033589)

Owner / Operator Contact Address

MAX-PLANCK-STRASSE 36, --, SPAICHINGEN, DE-BW D-78549, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-07-24
HTX	Rongeur	Orthopedic	Class 1	888.4540	2015-04-02
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2020-11-03
NNN	Crimper, Wire, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2017-07-24
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-03-21
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2017-07-19
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2024-11-24
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2017-01-18
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2005-05-02
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2019-05-16
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2019-01-18
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2017-12-12
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2015-06-08
NNQ	Forceps, Wire Closure, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2017-03-23
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2010-03-31
KBS	Punch, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2019-05-16
JYR	Nipper, Malleus	Ear, Nose, Throat	Class 1	874.4420	2017-09-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-05-16
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2005-05-02
KAO	Curette, Ethmoid	Ear, Nose, Throat	Class 1	874.4420	2018-12-12
KTF	Punch, Ent	Ear, Nose, Throat	Class 1	874.4420	2017-03-22
KBT	Punch, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2017-03-22
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-06-13
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	2017-03-20
KAW	Punch, Antrum	Ear, Nose, Throat	Class 1	874.4420	2016-12-18
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2019-06-13
JYW	Press, Vein	Ear, Nose, Throat	Class 1	874.4420	2016-09-14
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-03-22
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	2024-05-14
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2018-06-13
HWQ	Passer	Orthopedic	Class 1	888.4540	2019-04-10

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

EFINGER INSTRUMENTS GMBH & Co. KG

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
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K914226	E.I. Dupont DE Nemours & Co., Inc.	ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK	1991-11-19
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

Similar Registrations

Registration Number	Establishment Name	Location
8010298	RUDOLF MEDICAL GMBH + CO. KG	FRIDINGEN Baden-Wurttemberg, DE
8043496	REDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
8040373	NADEEM SURGICAL CORP. PRIVATE LTD.	SIALKOT Punjab, PK
2531475	URAMIX, INC.	E Lansdowne, PA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615004. Last updated year: 2026. Please use registration number 9615004 when referencing this establishment in official correspondence.