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FDA 510(k)

ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED

K-Number: K911819 · 1991-09-10

ApplicantAcra Cut, Inc.
Decision Date1991-09-10
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED 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 1991-09-10 under 510(k) number K911819. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED?

ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED is a medical device that received FDA 510(k) clearance on 1991-09-10. The listed applicant is Acra Cut, Inc.. The 510(k) number is K911819.

When did ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED receive FDA 510(k) clearance?

ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED received FDA 510(k) clearance on 1991-09-10, under 510(k) number K911819.

Who is the listed applicant for ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED?

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 NEUROLOGICAL SURGICAL DEVICE-POWERED?

The FDA product code for ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED is HBE.

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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.

K032970ACRA-CUT XPRESS 120K944311ACRA-CUTK911812ACRA-CUT WIRE PASS DRILLK910225BONE PAD REMOVERK910226DURAL DISSECTORSK892866AUTOMATIC CRANIAL DRILL (PERFORATOR)

View all 8 devices →

Related Devices (Code: HBE)

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.

K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)Surgify Medical OYK250815Hubly Drill (H100)Hubly, Inc.K252060GREENPhasor Health, LLCK252662UniBurNakanishi, Inc.K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)Surgify Medical OYK250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)Surgify Medical OY

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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