HUAIAN WOLFRAM SURGICAL INSTRUMENTS

FDA Device Registration & Listing · Huaian Jiangsu, CN · Registration 3003803182

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
3003803182
FEI Number
3003803182
Entity Name
HUAIAN WOLFRAM SURGICAL INSTRUMENTS
City/State/Country
Huaian Jiangsu, CN
Establishment Address
165 Songjiang rd., Huaian Jiangsu 223300, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
USIOL (Owner Number: 10027115)
Owner / Operator Contact Address
2500 sandersville rd, Lexington, KY 40511, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Wolfram Specula Ophthalmic Wolfram Curette Wolfram Forceps Ophthalmic Wolfram Retractor Ophthalmic Wolfram Instrument, Manual, Surgical, General Use Wolfram Forceps General and Plastic Surgery Wolfram Scissors Ophthalmic Wolfram Instrument Microsurgical Wolfram Knife Ophthalmic Wolfram Instruments Cardiovascular Wolfram Retractor Wolfram Hook General and Plastic Surgery

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2008-10-03
HTF Curette General, Plastic Surgery Class 1 878.4800 2008-10-03
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2008-10-03
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2008-10-03
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2008-10-03
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-10-03
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2008-10-03
GZX Instrument, Microsurgical Neurology Class 1 882.4525 2008-10-03
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2008-10-03
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2008-10-03
GAD Retractor General, Plastic Surgery Class 1 878.4800 2008-10-03
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-10-03

Official Correspondent

Derrick Johnson

US Agent Details

Derrick Johnson Business: USIOL Email: fangwei0230@hotmail.com Phone: (800) 3547848

Related Public Records

Same Entity

USIOL
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
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25
K821248 Conphar, Inc. ROCHESTER PEAN FORCEPS 1982-05-28
K874057 Myocure, Inc. OPHTHALMIC TIP & BLADE SCALPELS 1987-12-23
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-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 3003803182. Last updated year: 2026. Please use registration number 3003803182 when referencing this establishment in official correspondence.
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