Cleared Traditional

K944311 - ACRA-CUT
(FDA 510(k) Clearance)

K944311 · Acra Cut, Inc. · Neurology device

Nov 1994

Decision

77d

Days

Class 2

Risk

K944311 is an FDA 510(k) clearance for the ACRA-CUT. This device is classified as a Clip, Scalp (Class II - Special Controls, product code HBO).

Submitted by Acra Cut, Inc. (Acton, US). The FDA issued a Cleared decision on November 18, 1994, 77 days after receiving the submission on September 2, 1994.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4150.

Submission Details

510(k) Number	K944311 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 02, 1994
Decision Date	November 18, 1994
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement