Emprint HP

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Emprint HP FDA UDI
Generic Name: Microwave hyperthermia system FDA UDI
Device Name: Ablation Generator with Thermosphere Technology 150W;Caution: For manufacturing, processing, or repacking. FDA UDI
Model / Reference: CAGENHP FDA UDI
Description: Ablation Generator with Thermosphere Technology 150W;Caution: For manufacturing, processing, or repacking. FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521850033 FDA UDI
510(k) Number: K200796 FDA UDI
FDA Product Code: NEY FDA UDI
GMDN Term: Microwave hyperthermia system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Microwave hyperthermia system

Emprint HP by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microwave hyperthermia system.

HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II
BSD-500 Hyperthermia System — Pyrexar Medical, Inc. · Class III
HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II
BSD-2000 Hyperthermia System — Pyrexar Medical, Inc. · Unclassified
BSD-2000 Hyperthermia System — Pyrexar Medical, Inc. · Unclassified
Solero — ANGIODYNAMICS, INC · Class II
HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II
HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II

Cleared under the same submission

K200796 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI 2e1a04d7-f7de-4ff6-bd49-1c1df24b453a 37 fields · synced Jun 8, 2026