EMBLATION LIMITED

FDA Device Registration & Listing · Stirling, GB · Registration 3010933564

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
3010933564
FEI Number
3010933564
Entity Name
EMBLATION LIMITED
City/State/Country
Stirling, GB
Establishment Address
Emblation House, Castle Business Park, Stirling FK9 4TS, GB
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Emblation Limited (Owner Number: 10048070)
Owner / Operator Contact Address
Emblation House, Castle Business Park, Stirling, GB-STG FK9 4TS, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222388
PMA Number
N/A

All Registered Proprietary Names

Swift® System swiftPro Emprint Ablation System with Thermosphere Technology swiftPro swiftPro

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2018-12-10
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2025-12-17
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2020-09-02
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2024-06-24
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2014-12-03
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2023-08-13

Official Correspondent

Mairi MacFadyen

US Agent Details

Judy Snow Business: Judy Snow & Associates Email: judysnow@comcast.net Phone: (508) 9589532

Related Public Records

Same Entity

Emblation Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010933564. Last updated year: 2026. Please use registration number 3010933564 when referencing this establishment in official correspondence.
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