Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007353760

FEI Number

3007353760

Entity Name

ENERGIST LIMITED

City/State/Country

Swansea, GB

Establishment Address

2 Park Pavilions, Clos Llyn Cwm, Enterprise Park, Swansea SA6 8QY, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Energist Limited (Owner Number: 10027469)

Owner / Operator Contact Address

2 Park Pavilions, Clos Llyn Cwm, Enterprise Park, Swansea, GB-SWA SA6 8QY, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221873

PMA Number

N/A

All Registered Proprietary Names

NeoGen PSR System NeoGen PSR System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-01-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-01

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Energist 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
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
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

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

Similar Registrations

Registration Number	Establishment Name	Location
3005064998	RDI INC.	Mount Kisco, NY, US
3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US
3015506965	SMICNA PTE LTD	Singapore Central Singapore, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007353760. Last updated year: 2026. Please use registration number 3007353760 when referencing this establishment in official correspondence.