Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008711893

FEI Number

3008711893

Entity Name

B.Braun Medical (Suzhou) Co,.Ltd

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.128 Changyang Street, Suzhou Industrial Park, Suzhou Jiangsu 215024, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Aesculap AG (Owner Number: 8010193)

Owner / Operator Contact Address

Am Aesculap-Platz, Tuttlingen, DE-BW 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aesculap Aesculap TOOTH FORCEP Aesculap Aesculap Aesculap UTERINE CLAMP ACCESSORIES AND MANUAL SAW MANUAL SAW AND ACCESSORIES Aesculap SURGICAL RASP BIOPSY FORCEPS ENT FORCEPS Aesculap Aesculap SURGICAL ELEVATOR OSTEOTOME Aesculap Aesculap ANTRUM PUNCH Aesculap ORTHOPEDIC RASP Aesculap CERCLAGE INSTRUMENT SURGICAL DENTAL ELEVATOR ORTHOPEDIC FORCEPS Aesculap Aesculap SUSI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2008-07-29
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2008-07-29
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	1995-10-25
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1995-09-11
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1995-04-26
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	1995-04-26
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2001-10-01
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	1995-10-02
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1977-11-09
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1995-10-06
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2001-10-01
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	1995-10-11
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	1977-11-16
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	1996-03-18
HAD	Rongeur, Powered	Neurology	Class 2	882.4845	2008-07-30
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1995-09-18
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	1995-09-18
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	1995-12-22
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2015-05-22
KAW	Punch, Antrum	Ear, Nose, Throat	Class 1	874.4420	1995-10-18
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1995-09-18
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	1995-09-18
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	1995-09-11
HXN	Applier, Cerclage	Orthopedic	Class 1	888.4540	2005-04-11
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	1995-10-25
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2008-07-30
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1995-09-11
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1995-09-20
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1995-10-02

Official Correspondent

Kamaal Anas

US Agent Details

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

Related Public Records

Same Entity

Aesculap AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9681258	AESCULAP SAS	CHAUMONT Grand Est, FR
9610612	AESCULAP AG	TUTTLINGEN, DONAU Baden-Wurttemberg, DE

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
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

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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1646747	WEXLER SURGICAL, INC.	HOUSTON, TX, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008711893. Last updated year: 2026. Please use registration number 3008711893 when referencing this establishment in official correspondence.