Acra-Cut Xpress 120

Q: What is the product code of K032970?

The FDA product code is HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4305.

FDA 510(k) K032970 · Acra Cut, Inc.

Substantially Equivalent

510(k) numberK032970

Submission

Device name: Acra-Cut Xpress 120
Applicant: Acra Cut, Inc.
Amherst, NH, US
Received: September 23, 2003
Decision date: December 8, 2003
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered)
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4305
Specialty: Neurology

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More from Codman & Shurtleff, Inc.

510(k)	Device	Decision
K944311	Acra-CutHBO · Traditional	11/18/1994SE
K911819	Acra-Cut Neurological Surgical Device-PoweredHBE · Traditional	09/10/1991SE
K911812	Acra-Cut Wire Pass DrillHBE · Traditional	09/10/1991SE
K910226	Dural DissectorsHAO · Traditional	02/12/1991SE
K910225	Bone Pad RemoverHAO · Traditional	02/12/1991SE
K892866	Automatic Cranial Drill (Perforator)HBF · Traditional	06/15/1989SE
K833266	Acra-CutHBF · Traditional	12/29/1983SE

Questions and answers

When was Acra-Cut Xpress 120 cleared by the FDA?

Acra-Cut Xpress 120 (K032970) received a 510(k) decision of Substantially Equivalent on December 8, 2003, 76 days after the submission was received.

What is the product code of K032970?

The FDA product code is HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4305.