Emblation Inc.

FDA Device Registration & Listing · Lincoln, RI, US · Registration 3015152398

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
3015152398
FEI Number
3015152398
Entity Name
Emblation Inc.
City/State/Country
Lincoln, RI, US
Establishment Address
42 Albion Rd, Lincoln, RI 02865, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Emblation Inc. (Owner Number: 10059260)
Owner / Operator Contact Address
42 Albion Road, Suite 106, Lincoln, RI 02865, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K250718
PMA Number
N/A

All Registered Proprietary Names

swiftPro 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 2026-06-08
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2026-06-08
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2026-06-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Emblation Inc.
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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3022977243 Varian Medical Systems, Inc. Shoreview, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015152398. Last updated year: 2026. Please use registration number 3015152398 when referencing this establishment in official correspondence.
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