FDA 510(k)

ACRA-CUT WIRE PASS DRILL

K-Number: K911812 · 1991-09-10

Decision Date1991-09-10

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ACRA-CUT WIRE PASS DRILL 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 K911812. 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 WIRE PASS DRILL?

ACRA-CUT WIRE PASS DRILL 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 K911812.

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

ACRA-CUT WIRE PASS DRILL received FDA 510(k) clearance on 1991-09-10, under 510(k) number K911812.

Who is the listed applicant for ACRA-CUT WIRE PASS DRILL?

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 WIRE PASS DRILL?

The FDA product code for ACRA-CUT WIRE PASS DRILL is HBE.

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Other records listing Acra Cut, Inc. as applicant

K032970ACRA-CUT XPRESS 120 K944311ACRA-CUT K911819ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED K910225BONE PAD REMOVER K910226DURAL DISSECTORS K892866AUTOMATIC CRANIAL DRILL (PERFORATOR)

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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.