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FDA 510(k)

ACRA-CUT XPRESS 120

K-Number: K032970 · 2003-12-08

ApplicantAcra Cut, Inc.
Decision Date2003-12-08
Product CodeHBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACRA-CUT XPRESS 120 is the device name listed in this FDA 510(k) record. The listed applicant is Acra Cut, Inc.. It received FDA 510(k) clearance on 2003-12-08 under 510(k) number K032970. The device is classified under product code HBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRA-CUT XPRESS 120?

ACRA-CUT XPRESS 120 is a medical device that received FDA 510(k) clearance on 2003-12-08. The listed applicant is Acra Cut, Inc.. The 510(k) number is K032970.

When did ACRA-CUT XPRESS 120 receive FDA 510(k) clearance?

ACRA-CUT XPRESS 120 received FDA 510(k) clearance on 2003-12-08, under 510(k) number K032970.

Who is the listed applicant for ACRA-CUT XPRESS 120?

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

What is the FDA product code for ACRA-CUT XPRESS 120?

The FDA product code for ACRA-CUT XPRESS 120 is HBF.

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Other records listing Acra Cut, 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.

K944311ACRA-CUTK911819ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWEREDK911812ACRA-CUT WIRE PASS DRILLK910225BONE PAD REMOVERK910226DURAL DISSECTORSK892866AUTOMATIC CRANIAL DRILL (PERFORATOR)

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Related Devices (Code: HBF)

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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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