ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED— 510(k) K911819

Name: FDA 510(k) clearance K911819
Creator: U.S. Food and Drug Administration
Published: 1991-09-10

Substantially Equivalent

Acra Cut, Inc.

FDA 510(k) clearance K911819 for ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED, Substantially Equivalent on 1991-09-10. Applicant: Acra Cut, Inc.. Device class: 2.

Clearance details

Applicant: Acra Cut, Inc.
Product code: Code HBE
Device class: Class 2
Regulation: 21 CFR 882.4310
Advisory panel: Neurology
Date received: 1991-04-24
Decision date: 1991-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Acra Cut, Inc.

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K032970 — ACRA-CUT XPRESS 1202003-12-08
K944311 — ACRA-CUT1994-11-18
K911812 — ACRA-CUT WIRE PASS DRILL1991-09-10
K910225 — BONE PAD REMOVER1991-02-12
K910226 — DURAL DISSECTORS1991-02-12

Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.