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FDA 510(k)

ECHOSTIM FACET TIP

K-Number: K063380 · 2007-04-25

ApplicantHavel'S, Inc.
Decision Date2007-04-25
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ECHOSTIM FACET TIP is the device name listed in this FDA 510(k) record. The listed applicant is Havel'S, Inc.. It received FDA 510(k) clearance on 2007-04-25 under 510(k) number K063380. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOSTIM FACET TIP?

ECHOSTIM FACET TIP is a medical device that received FDA 510(k) clearance on 2007-04-25. The listed applicant is Havel'S, Inc.. The 510(k) number is K063380.

When did ECHOSTIM FACET TIP receive FDA 510(k) clearance?

ECHOSTIM FACET TIP received FDA 510(k) clearance on 2007-04-25, under 510(k) number K063380.

Who is the listed applicant for ECHOSTIM FACET TIP?

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

What is the FDA product code for ECHOSTIM FACET TIP?

The FDA product code for ECHOSTIM FACET TIP is BSP.

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.

Related Devices (Code: BSP)

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.

Official Source

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

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