AUTOMATIC CRANIAL DRILL (PERFORATOR)— 510(k) K892866

Name: FDA 510(k) clearance K892866
Creator: U.S. Food and Drug Administration
Published: 1989-06-15

Substantially Equivalent

Acra Cut, Inc.

FDA 510(k) clearance K892866 for AUTOMATIC CRANIAL DRILL (PERFORATOR), Substantially Equivalent on 1989-06-15. Applicant: Acra Cut, Inc.. Device class: 2.

Clearance details

Applicant: Acra Cut, Inc.
Product code: Code HBF
Device class: Class 2
Regulation: 21 CFR 882.4305
Advisory panel: Neurology
Date received: 1989-04-19
Decision date: 1989-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

Download summary PDF View on FDA.gov ↗

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K183581 — Codman Disposable Perforators2019-01-20
K141455 — EASYDRILL AUTOSTOP CRANIAL PERFORATOR2015-03-16

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
K911819 — ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED1991-09-10
K910225 — BONE PAD REMOVER1991-02-12

Adverse events under product code HBF

product code HBF

Injury: 587
Malfunction: 621
Other: 1
Total: 1,209

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.