Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010433

FEI Number

3003200061

Entity Name

e.l. zepf GmbH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

GOTENSTRASSE 5, TUTTLINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

e.l. zepf GmbH (Owner Number: 8010433)

Owner / Operator Contact Address

GOTENSTRASSE 5, --, TUTTLINGEN, DE-BW D-78532, 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
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	1997-02-12
KCD	Bougie, Esophageal, Ent	Ear, Nose, Throat	Class 1	874.4420	2004-07-19
KCF	Dilator, Esophageal, Ent	Ear, Nose, Throat	Class 1	874.4420	2004-07-19
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2013-01-31
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2013-01-31
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1986-08-20
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1978-06-28
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2015-06-19
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-31
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1979-06-01
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-31
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1997-02-12
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	1979-06-01
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	1983-09-27
KAG	Holder, Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2004-07-19
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-12-11
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	1997-02-12
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1979-06-01
KAJ	Mobilizer, Ent	Ear, Nose, Throat	Class 1	874.4420	2004-07-19
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	1983-09-27
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2015-07-27
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2015-06-19
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2015-06-19
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1983-09-27
JZY	Knife, Laryngeal	Ear, Nose, Throat	Class 1	874.4420	2015-06-19
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2015-06-19
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1978-06-28
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	1986-10-30
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2004-07-19

Official Correspondent

No official correspondent registered.

US Agent Details

Beate Weiss-Krull Business: Beate Weiss-Krull, Attorney at Law Email: bea@weisskrull-law.com Phone: (503) 2340355

Related Public Records

Same Entity

e.l. zepf 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
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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3010726901	EVONOS GMBH & CO. KG	Tuttlingen Baden-Wurttemberg, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010433. Last updated year: 2026. Please use registration number 8010433 when referencing this establishment in official correspondence.