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510(k) K944311

ACRA-CUT by Acra Cut, Inc. — Product Code HBO

K944311 is an FDA 510(k) premarket notification submitted by Acra Cut, Inc. for the device "ACRA-CUT". The FDA issued a decision of Substantially Equivalent on November 18, 1994. The device falls under product code HBO (Clip, Scalp), a Class II device regulated under 21 CFR 882.4150. Acra Cut, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1994
Date Received
September 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Scalp
Device Class
Class II
Regulation Number
882.4150
Review Panel
NE
Submission Type

Other clearances by Acra Cut, Inc.

  • K032970 — ACRA-CUT XPRESS 120 (December 8, 2003)
  • K911812 — ACRA-CUT WIRE PASS DRILL (September 10, 1991)
  • K911819 — ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED (September 10, 1991)
  • K910225 — BONE PAD REMOVER (February 12, 1991)
  • K910226 — DURAL DISSECTORS (February 12, 1991)
  • K892866 — AUTOMATIC CRANIAL DRILL (PERFORATOR) (June 15, 1989)
  • K833266 — ACRA-CUT (December 29, 1983)

Other clearances for product code HBO

  • K050044 — MEDTRONIC CLIP GUN KIT (February 7, 2005)
  • K033660 — STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 (January 7, 2004)
  • K012219 — SCALPFIX CLIP SYSTEM (July 31, 2001)
  • K905433 — CODMAN DISPOSABLE SCALP CLIP APPLIER (February 21, 1991)
  • K896723 — CLIP GUN WITH RANEY TYPE SCALP CLIPS (March 23, 1990)
  • K894778 — CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER (December 6, 1989)
  • K890443 — CASPAR SCALP CLIP, APPLIER (June 15, 1989)
  • K883963 — RANEY AND LEROY-RANEY SCALP CLIP (October 7, 1988)
  • K881265 — RANEY CLIPS (May 31, 1988)

FDA data resources