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FDA 510(k)

ACRA-CUT

K-Number: K944311 · 1994-11-18

ApplicantAcra Cut, Inc.
Decision Date1994-11-18
Product CodeHBO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACRA-CUT 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 1994-11-18 under 510(k) number K944311. The device is classified under product code HBO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRA-CUT?

ACRA-CUT is a medical device that received FDA 510(k) clearance on 1994-11-18. The listed applicant is Acra Cut, Inc.. The 510(k) number is K944311.

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

ACRA-CUT received FDA 510(k) clearance on 1994-11-18, under 510(k) number K944311.

Who is the listed applicant for ACRA-CUT?

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?

The FDA product code for ACRA-CUT is HBO.

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.

K032970ACRA-CUT XPRESS 120K911819ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWEREDK911812ACRA-CUT WIRE PASS DRILLK910225BONE PAD REMOVERK910226DURAL DISSECTORSK892866AUTOMATIC CRANIAL DRILL (PERFORATOR)

View all 8 devices →

Related Devices (Code: HBO)

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.

K253814Raney Clips KitBeijing Honghugaoxiang Science and Technology Development COK050044MEDTRONIC CLIP GUN KITMedtronic NeurosurgeryK033660STORZ RANEY SCALP CLIP, MODEL 1-20-004-05Rudolf Storz GmbHK012219SCALPFIX CLIP SYSTEMAesculap, Inc.K905433CODMAN DISPOSABLE SCALP CLIP APPLIERCodman & Shurtleff, Inc.K896723CLIP GUN WITH RANEY TYPE SCALP CLIPSOmni Medical Designs

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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