Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010769

FEI Number

7282

Entity Name

KAPP SURGICAL GMBH

City/State/Country

DUERBHEIM Baden-Wurttemberg, DE

Establishment Address

5. HAUPTSTRASSE, DUERBHEIM Baden-Wurttemberg D-78589, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KAPP SURGICAL GMBH (Owner Number: 8010769)

Owner / Operator Contact Address

5. HAUPTSTRASSE, --, DUERBHEIM, DE-NOTA D-78589, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Kerrison Rongeurs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	1997-11-25
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	1997-11-25
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1997-09-23
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2016-01-21
HTX	Rongeur	Orthopedic	Class 1	888.4540	1985-02-26
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-02-27
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	1985-02-26
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	1997-11-25
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2010-11-17
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2013-02-28
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2015-02-12
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-27
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2016-12-01
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	1998-05-27
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-02-27
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-27
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-02-28
JZA	Rongeur, Mastoid	Ear, Nose, Throat	Class 1	874.4420	2013-02-26
HXG	Tamp	Orthopedic	Class 1	888.4540	2013-02-26
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-02-27
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2013-09-03
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2014-04-25
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2013-02-27
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-02-27
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-02-26
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2013-02-28
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-02-26
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2005-01-04
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2016-12-01
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2013-02-27
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-02-27
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-02-27
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-26
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2013-03-11
KAX	Punch, Ethmoid	Ear, Nose, Throat	Class 1	874.4420	2013-02-27

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

KAPP SURGICAL 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
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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
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

Similar Registrations

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1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
3013508670	Ormco Corporation	Pomona, CA, US
3009171220	DENTIMED SAO JOAO	Sunrise, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010769. Last updated year: 2026. Please use registration number 8010769 when referencing this establishment in official correspondence.