Medical Device Manufacturer · US , Acton , MA

Acra Cut, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1983

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Acra Cut, Inc. Neurology ✕

8 devices

1-8 of 8

Cleared Dec 08, 2003

ACRA-CUT XPRESS 120

Neurology · 76d

Cleared Nov 18, 1994

Neurology · 77d

Cleared Sep 10, 1991

ACRA-CUT WIRE PASS DRILL

Neurology · 139d

Cleared Sep 10, 1991

ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED

Neurology · 139d

Cleared Feb 12, 1991

BONE PAD REMOVER

Neurology · 25d

Cleared Feb 12, 1991

DURAL DISSECTORS

Neurology · 25d

Cleared Jun 15, 1989

AUTOMATIC CRANIAL DRILL (PERFORATOR)

Neurology · 57d

Cleared Dec 29, 1983

Neurology · 99d