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FDA 510(k)

ACCUREX

K-Number: K061126 · 2006-05-09

ApplicantCybermed, Inc.
Decision Date2006-05-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCUREX is the device name listed in this FDA 510(k) record. The listed applicant is Cybermed, Inc.. It received FDA 510(k) clearance on 2006-05-09 under 510(k) number K061126. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUREX?

ACCUREX is a medical device that received FDA 510(k) clearance on 2006-05-09. The listed applicant is Cybermed, Inc.. The 510(k) number is K061126.

When did ACCUREX receive FDA 510(k) clearance?

ACCUREX received FDA 510(k) clearance on 2006-05-09, under 510(k) number K061126.

Who is the listed applicant for ACCUREX?

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

What is the FDA product code for ACCUREX?

The FDA product code for ACCUREX is LLZ.

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Other records listing Cybermed, 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.

K210039CORE1 Implant SystemK113543ONDEMAND3DK070464ONDEMAND3DK053155VIMPLANTK013878CYBERMED, INC., V-WORKS

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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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