Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014925413

FEI Number

3014925413

Entity Name

CREO MEDICAL LTD

City/State/Country

CHEPSTOW Monmouthshire, GB

Establishment Address

Unit 2, Beaufort Park, Beaufort Park Road, CHEPSTOW Monmouthshire NP16 5UH, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Creo Medical Ltd (Owner Number: 10058797)

Owner / Operator Contact Address

Creo House, Unit 2 Beaufort Park, Beaufort Park Way, CHEPSTOW, GB-MON NP16 5UH, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242061

PMA Number

N/A

All Registered Proprietary Names

CROMA Electrosurgical Generator Creo Electrosurgical System with NP1 Instrument SpydrBlade Flex Speedboat CROMA Electrosurgical System Footswitch (7-PG1-132) Reusable Interface Cable 1.5 m (PRD-IFC-002)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2025-02-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-02-06
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2025-02-06
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2024-02-19
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2025-06-09
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2018-10-29
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2024-08-16

Official Correspondent

Steven Patterson

US Agent Details

Richard Weir Business: Creo Medical Inc. Email: richard.weir@creomedical.com Phone: (203) 9171770

Related Public Records

Same Entity

Creo Medical Ltd

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
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0210-2022	Covidien Llc	2	Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

Similar Registrations

Registration Number	Establishment Name	Location
3013526170	Jiangsu Vedkang Medical Science and Technology Co.,Ltd.	Changzhou Jiangsu, CN
1000121056	Boston Scientific Corporation	Coventry, RI, US
3002807310	Synergy Health Sterilisation UK Ltd	Berkshire Reading, GB
1320894	CONMED CORPORATION	Utica, NY, US
3014769442	Aomori Olympus Co., Ltd. Hirosaki Site	Hirosaki-shi Aomori, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014925413. Last updated year: 2026. Please use registration number 3014925413 when referencing this establishment in official correspondence.