Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680260

FEI Number

3002315844

Entity Name

AESCULAP CHIFA SP. Z O.O.

City/State/Country

NOWY TOMYSL Wielkopolskie, PL

Establishment Address

UL. TYSIACLECIA 14, NOWY TOMYSL Wielkopolskie 64-300, PL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AESCULAP CHIFA SP. Z O. O. (Owner Number: 9007699)

Owner / Operator Contact Address

UL. TYSIACLECIA 14, --, NOWY TOMYSL, PL-30 64-300, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RETRACTOR VARIOUS TYPES OF GOUGES LAMBOTTE) (ALEXANDER GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY INSTRUMENT, CUTTING, ORTHOPEDIC MALLET, SURGICAL, GENERAL & PLASTIC SURGERY VARIOUS TYPES OF RETRACTORS FORCEPS, GENERAL & PLASTIC SURGERY FORCEPS MAGNUM MEDICAL INC. Aesculap VARIOUS TYPES OF ENGLIS FORCEPS, TOOTH EXTRACTOR, SURGICAL LIGATURE VARIOUS MODELS SURGICAL DENTAL ELEVATORS ELEVATOR, SURGICAL, DENTAL NAIL) CUTTERS VARIOUS TYPES OF SURGICAL (WIRE MULTIPLE SURGICAL FILES FILE, SURGICAL, GENERAL & PLASTIC SURGERY Aesculap FORCEPS, RONGEUR, SURGICAL MULTIPLE MICROSURGICAL INSTRUMENTS INSTRUMENT, MICROSURGICAL FORCEPS MC PHERSON FORCEPS, OPHTHALMIC SCISSORS, GENERAL, SURGICAL VARIOUS TYPES OF SURG ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL CROWN SCISSORS SCISSORS, COLLAR AND CROWN HOLDER, NEEDLE, GASTROENTEROLOGIC FORCEPS, RUBBER DAM CLAMP BREWER AIMSWORTH VARIOUS TYPES AND SIZES OF SCISSORS SCISSORS, SURGICAL TISSUE, DENTAL PLIER, ORTHODONTIC PLIERS, SURGICAL BAND HOLDERS HOW LIGATURE PLIERS FURRER PLIERS MEDICAL DISPOSABLE SCISSORS GENTOFT FENO SPECULUM, VAGINAL, METAL TOWEL CLAMPS SIZES BACKHAUS , VARIOUS TYPES CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2013-12-16
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1998-07-02
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2006-03-08
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1998-07-02
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-07-15
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2006-03-08
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-10-02
EJY	Pliers, Operative	Dental	Class 1	872.4565	2013-03-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-06-12
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2006-03-08
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	1993-11-24
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2006-03-08
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-03-08
GEO	File, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2006-03-08
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2026-06-12
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1998-07-02
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2006-03-08
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2006-03-08
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1998-07-02
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2006-03-08
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2018-01-03
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-08-05
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	1998-07-02
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2006-03-08
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1998-10-02
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2006-03-08
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2006-03-08
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1998-07-02
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	1993-11-24
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	1998-07-02
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2006-03-08
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2019-03-05
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2006-03-08
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2006-03-08
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2006-03-08

Official Correspondent

TOMASZ KLUJ

US Agent Details

Kamaal Anas Business: Aesculap, Inc. Email: kamaal.anas@bbraunusa.com Phone: (610) 9849071

Related Public Records

Same Entity

AESCULAP CHIFA SP. Z O. O.

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
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
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical 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
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680260. Last updated year: 2026. Please use registration number 9680260 when referencing this establishment in official correspondence.