Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012644327

FEI Number

3012644327

Entity Name

CORE SURGICAL LIMITED

City/State/Country

Thame Oxfordshire, GB

Establishment Address

Unit B5 Station Yard, Thame Oxfordshire OX9 3UH, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Core Surgical Limited (Owner Number: 10051443)

Owner / Operator Contact Address

Unit B5 Station Yard, Thame, GB-OXF OX9 3UH, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Windsor Knife

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-03-18

Official Correspondent

Ian Hutchinson

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

Core Surgical Limited

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
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

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 3012644327. Last updated year: 2026. Please use registration number 3012644327 when referencing this establishment in official correspondence.