← Back to catalogue

Coretherm System Microwave Thermotherapy

FDA PMAFDA UDIEUDAMED

Class III (US FDA PMA)

PMA P010055Ref CA804220Ref CA804120

by Prostalund AB

Identity

Trade Name
CoreTherm EUDAMEDFDA UDI
PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH FDA PMA
Generic Name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy FDA PMA
Microwave hyperthermia system applicator, intracorporeal FDA UDI
Device Name
CoreTherm Catheter Standard EUDAMED
Model / Reference
CA804220 EUDAMED
CA804120 EUDAMED
Catheter Standard FDA UDI
Catheter Short FDA UDI

Identifiers

Catalog Number
CA804220 FDA UDI
CA804120 FDA UDI
Primary DI / UDI-DI
07350081910051 EUDAMEDFDA UDI
07350081910082 EUDAMEDFDA UDI
Basic UDI-DI
0735008191CA804X20Q8 EUDAMED
PMA Number
P010055 FDA PMA
FDA Product Code
MEQ FDA PMAFDA UDI
EMDN Code
Z12160301 EQUIPMENT FOR MICROWAVE PROSTATE THERMOTHERAPY EUDAMED
GMDN Term
Microwave hyperthermia system applicator, intracorporeal FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class III FDA PMAFDA UDI
Market of Registration
Sweden EUDAMED
Advisory Committee
Gastroenterology, Urology FDA PMA
FDA Decision
APPR Approved FDA PMA
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

The Coretherm System is a microwave thermotherapy device designed to provide non-surgical, minimally invasive relief for symptoms associated with benign prostatic hyperplasia (BPH). It utilizes Prostalund Feedback Treatment (PLFT) to deliver targeted microwave energy to the prostate tissue.

This system is indicated for use in men with a prostate size ranging from 30 to 100g and a prostatic urethra length of at least 35 mm. The device is manufactured by Prostalund AB and holds FDA PMA, MDD, and MDR authorizations.

Frequently asked questions

What is the Coretherm System used for?

The Coretherm System is intended to relieve symptoms associated with symptomatic benign prostatic hyperplasia (BPH) by using microwave thermotherapy.

Who is a candidate for Coretherm treatment?

The device is indicated for men who have a prostate size between 30 and 100g and a prostatic urethra length of 35 mm or greater.

Is the Coretherm procedure surgical?

No, the Coretherm System is a non-surgical, minimally invasive device that uses microwave energy to treat BPH symptoms.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - CoreTherm, For healthcare professionals - CoreTherm, AUA Guidelines and Their Impact on the Management of BPH - PMC, A Temporary Intraurethral Prostatic Stent Relieves Prostatic ..., Treatments for Benign Prostatic Hyperplasia - CMS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Pending data

MDR

United States Active

FDA_PMA

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Prostalund AB

Sources (5)

  • FDA PMA P010055 24 fields · synced Sep 18, 2026
  • FDA UDI 33566923-ad20-404c-a906-54b0193c6e9c 34 fields · synced May 29, 2026
  • FDA UDI 46e7f2df-9334-487c-9d0c-1c930eadda18 34 fields · synced May 30, 2026
  • EUDAMED 116abe8c-f15b-4b41-8cc7-2acaf0e84d4e 61 fields · synced Jul 19, 2026
  • EUDAMED 3a244c15-3a94-40f0-84a3-321427e874ef 61 fields · synced Jul 21, 2026