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FDA 510(k)

EPICOR MEDICAL ABLATION SYSTEM

K-Number: K022894 · 2004-02-26

ApplicantEpicor Medical, Inc.
Decision Date2004-02-26
Product CodeNTB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPICOR MEDICAL ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Epicor Medical, Inc.. It received FDA 510(k) clearance on 2004-02-26 under 510(k) number K022894. The device is classified under product code NTB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPICOR MEDICAL ABLATION SYSTEM?

EPICOR MEDICAL ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-26. The listed applicant is Epicor Medical, Inc.. The 510(k) number is K022894.

When did EPICOR MEDICAL ABLATION SYSTEM receive FDA 510(k) clearance?

EPICOR MEDICAL ABLATION SYSTEM received FDA 510(k) clearance on 2004-02-26, under 510(k) number K022894.

Who is the listed applicant for EPICOR MEDICAL ABLATION SYSTEM?

The FDA 510(k) record lists Epicor Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPICOR MEDICAL ABLATION SYSTEM?

The FDA product code for EPICOR MEDICAL ABLATION SYSTEM is NTB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Epicor Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K040641ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1

Related Devices (Code: NTB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.K070779SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEMMisonix, Inc.K060346ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEMUltrazonix Dnt ABK042096MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEMMisonix, Inc.K040641ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1Epicor Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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