XINHUA SURGICAL INSTRUMENT CO. LTD.

FDA Device Registration & Listing · ZIBO Shandong, CN · Registration 3005440795

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005440795
FEI Number
3005440795
Entity Name
XINHUA SURGICAL INSTRUMENT CO. LTD.
City/State/Country
ZIBO Shandong, CN
Establishment Address
No. 2779 Qixiang Road, Zibo New and Hi-tech Zone, ZIBO Shandong 255086, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
XINHUA SURGICAL INSTRUMENT CO. LTD. (Owner Number: 9079079)
Owner / Operator Contact Address
No. 7 Taimei Road,, --, ZIBO SHANDONG, CN-NOTA 255086, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

stainless steel suction tubes stainless steel cannula laryngeal mirror Shinva or Xinhua surgical instruments DENTAL INSTRUMENT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2005-10-31
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2005-10-31
HTD Forceps General, Plastic Surgery Class 1 878.4800 2007-11-02
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2007-11-02
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2010-12-02
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2005-10-31
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2009-12-16
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2009-12-16
EMN Scaler, Periodontic Dental Class 1 872.4565 2007-11-02
JYZ Rod, Measuring Ear Ear, Nose, Throat Class 1 874.4420 2010-12-02
JYH Excavator, Ear Ear, Nose, Throat Class 1 874.4420 2010-12-02
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2005-10-31
FHB Hook, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2005-10-31
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 2005-10-31
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 2009-12-16
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 2010-12-02
HBS Instrument, Clip Forming/Cutting Neurology Class 1 882.4190 2007-11-02
HTF Curette General, Plastic Surgery Class 1 878.4800 2005-10-31
GCZ Retainer, Surgical General, Plastic Surgery Class 1 878.4800 2009-12-16
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2010-12-02
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2017-12-07
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2010-12-02
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2009-12-16
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2010-12-02
HBQ Instrument, Clip Removal Neurology Class 1 882.4200 2007-11-02
EMI File, Bone, Surgical Dental Class 1 872.4565 2005-10-31
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 2009-12-16
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2009-12-16
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2010-12-02
GEO File, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2005-10-31
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-12-07
KCH Hook, Tracheal Ear, Nose, Throat Class 1 874.4420 2010-12-02
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2005-10-31
JYE Chisel, Middle-Ear Ear, Nose, Throat Class 1 874.4420 2010-12-02
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2010-12-02
FOB Bedpan General Hospital Class 1 880.6730 2009-12-16
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2005-10-31
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2010-12-02
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2005-10-31
KAG Holder, Speculum, Ent General, Plastic Surgery Class 1 878.1800 2009-12-16
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2009-12-16
FNS Ring Cutter General Hospital Class 1 880.6200 2009-12-16
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2009-12-16
FZQ Clip, Removable (Skin) General, Plastic Surgery Class 1 878.4320 2007-11-02
KBB Rongeur, Nasal Ear, Nose, Throat Class 1 874.4420 2010-12-02
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 2005-10-31
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2009-12-16
HAS Needle, Neurosurgical Suture Neurology Class 1 882.4650 2007-11-02
DZN Instruments, Dental Hand Dental Class 1 872.4565 2005-10-31
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2009-12-16
EKI Carrier, Amalgam, Operative Dental Class 1 872.4565 2005-10-31
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2005-10-31
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2005-10-31
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2009-12-16
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 2005-10-31
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2007-11-02
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2009-12-16
HSO Saw General, Plastic Surgery Class 1 878.4800 2007-11-02
FJX Ring, Crimp Gastroenterology, Urology Class 1 876.5540 2007-11-02
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2009-12-16
HNY Cystotome Ophthalmic Class 1 886.4350 2010-12-02
GAD Retractor General, Plastic Surgery Class 1 878.4800 2005-10-31
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2010-12-02
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2005-10-31
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2005-10-31
HGD Applicator, Vaginal Obstetrics/Gynecology Class 1 884.4520 2005-10-31
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2009-12-16
HXD Clamp General, Plastic Surgery Class 1 878.4800 2005-10-31
EMK Curette, Surgical, Dental Dental Class 1 872.4565 2009-12-16
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2018-12-10
NJZ Extractor, Vein General, Plastic Surgery Class 1 878.4800 2009-12-16
HXR Spatula, Orthopedic General, Plastic Surgery Class 1 878.4800 2007-11-02
FHM Apparatus, Suturing, Stomach And Intestinal General, Plastic Surgery Class 1 878.4800 2007-11-02
FHL Scoop Gastroenterology, Urology Class 1 876.4730 2005-10-31
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 2009-12-16
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2005-10-31
FNY Basin, Emesis General Hospital Class 1 880.6730 2009-12-16
HXY Brace, Drill Orthopedic Class 1 888.4540 2005-10-31
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2010-12-02
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 2009-12-16
GXJ Punch, Skull Neurology Class 1 882.4750 2007-11-02
HWK Trephine Orthopedic Class 1 888.4540 2005-10-31
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-11-02
GFB Head, Surgical, Hammer General, Plastic Surgery Class 1 878.4820 2009-12-16
MKY System, Skin Closure General, Plastic Surgery Class 1 878.4320 2009-12-16
EMD Hemostat, Surgical Dental Class 1 872.4565 2005-10-31
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-11-02
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2009-12-16
EME Punch, Biopsy, Surgical Dental Class 1 872.4565 2005-10-31
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2005-10-31
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2005-10-31
FHI Ring, Laparotomy Gastroenterology, Urology Class 1 876.4730 2007-11-02
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2007-11-02
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2005-10-31
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2009-12-16
HOD Clamp, Eyelid, Ophthalmic Ophthalmic Class 1 886.4350 2010-12-02
FFN Clamp, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2005-10-31
FHR Needle, Gastro-Urology General, Plastic Surgery Class 1 878.4800 2007-11-02
HBR Rack, Clip Neurology Class 1 882.4215 2007-11-02
HWA Impactor Orthopedic Class 1 888.4540 2005-10-31
HTP File Orthopedic Class 1 888.4540 2005-10-31
HBM Headrest, Neurosurgical Neurology Class 1 882.4440 2005-10-31
HOC Clip, Iris Retractor Ophthalmic Class 1 886.4350 2010-12-02
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 2007-11-02
FBX Sound, Urethral, Metal Or Plastic Gastroenterology, Urology Class 1 876.5520 2009-12-16
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2010-12-02
KTF Punch, Ent Ear, Nose, Throat Class 1 874.4420 2007-11-02
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2009-12-16
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2010-12-02
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2009-12-16
JZA Rongeur, Mastoid Ear, Nose, Throat Class 1 874.4420 2010-12-02
EIK Carver, Wax, Dental Dental Class 1 872.4565 2005-10-31
FCH Tray, Biopsy, Without Biopsy Instruments Gastroenterology, Urology Class 1 876.4730 2009-12-16
EKH Carver, Dental Amalgam, Operative Dental Class 1 872.4565 2005-10-31
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2007-11-02
EKE Curette, Operative Dental Class 1 872.4565 2005-10-31
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2005-10-31
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2005-10-31
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2005-10-31
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2009-12-16
EJL Bur, Dental Dental Class 1 872.3240 2007-11-02
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2005-10-31
EAX Mirror, Mouth Dental Class 1 872.4565 2009-12-16
EKJ Burnisher, Operative Dental Class 1 872.4565 2005-10-31
GWX Fork, Tuning Neurology Class 1 882.1525 2009-12-16
HBD Handpiece (Brace), Drill Neurology Class 1 882.4325 2007-11-02
HMG Stand, Instrument, Ophthalmic, Non-Powered Ophthalmic Class 1 886.1860 2009-12-16
DWH Blade, Saw, Surgical, Cardiovascular General, Plastic Surgery Class 1 878.4820 2009-12-16
JZD Snare, Ear Ear, Nose, Throat Class 1 874.4420 2010-12-02
EKD Instrument, Cutting, Operative Dental Class 1 872.4565 2009-12-16
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2005-10-31
JZE Spoon, Ear Ear, Nose, Throat Class 1 874.4420 2010-12-02
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2009-12-16
DZM Needle, Dental Dental Class 1 872.4730 2007-11-02
HTR Rasp General, Plastic Surgery Class 1 878.4800 2005-10-31
KAH Microrule, Ent Ear, Nose, Throat Class 1 874.4420 2010-12-02
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2005-10-31
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2009-12-16
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2005-10-31
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2007-11-02
JYK Holder, Ear Speculum General, Plastic Surgery Class 1 878.1800 2009-12-16
HDK Scissors, Episiotomy Obstetrics/Gynecology Class 1 884.4520 2005-10-31
EKA File, Margin Finishing, Operative Dental Class 1 872.4565 2007-11-02
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2005-10-31
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 2010-12-02
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2005-10-31
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2007-11-02
HWO Skid, Bone Orthopedic Class 1 888.4540 2010-12-02
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-11-02
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2005-10-31
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2005-10-31
HTW Bit, Drill Orthopedic Class 1 888.4540 2005-10-31
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 2005-10-31
GZX Instrument, Microsurgical Neurology Class 1 882.4525 2005-10-31
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2007-11-02
JCY Catheter, Infusion General, Plastic Surgery Class 1 878.4200 2007-11-02
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2005-10-31
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 2010-12-02
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2005-10-31
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2005-10-31
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 2009-12-16
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2005-10-31
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2005-10-31
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2009-12-16
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2005-10-31
HHF Remover, Intrauterine Device, Contraceptive, Hook-Type Obstetrics/Gynecology Class 1 884.4530 2005-10-31
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 2007-11-02

Official Correspondent

Jessy Luo

US Agent Details

Ling Pang Business: Advanced Meditech International Inc. Email: jessy.luo@163.com Phone: (718) 3522981

Related Public Records

Same Entity

XINHUA SURGICAL INSTRUMENT CO. LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

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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
K851721 Artiberia 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS 1985-07-02
K914226 E.I. Dupont DE Nemours & Co., Inc. ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK 1991-11-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-04 Surgical Specialties Corp 1
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024 Alcon Research LLC Aspex Facility 1
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024 Alcon Research LLC Aspex Facility 1
ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024 Alcon Research LLC Aspex Facility 1
ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024 Alcon Research LLC Aspex Facility 1
ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005440795. Last updated year: 2026. Please use registration number 3005440795 when referencing this establishment in official correspondence.
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