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510(k) K032970

ACRA-CUT XPRESS 120 by Acra Cut, Inc. — Product Code HBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2003
Date Received
September 23, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Compound, Powered)
Device Class
Class II
Regulation Number
882.4305
Review Panel
NE
Submission Type

Other clearances by Acra Cut, Inc.

  • K944311 — ACRA-CUT (November 18, 1994)
  • K911812 — ACRA-CUT WIRE PASS DRILL (September 10, 1991)
  • K911819 — ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED (September 10, 1991)
  • K910226 — DURAL DISSECTORS (February 12, 1991)
  • K910225 — BONE PAD REMOVER (February 12, 1991)
  • K892866 — AUTOMATIC CRANIAL DRILL (PERFORATOR) (June 15, 1989)
  • K833266 — ACRA-CUT (December 29, 1983)

Other clearances for product code HBF

  • K231403 — evoDrill Cranial Perforator (March 6, 2024)
  • K213228 — NeuroLine Disposable Cranial Perforator with Hudson end (June 20, 2022)
  • K183581 — Codman Disposable Perforators (January 20, 2019)
  • K141455 — EASYDRILL AUTOSTOP CRANIAL PERFORATOR (March 16, 2015)
  • K121253 — MERIDIAN CRANIAL PERFORATOR (July 17, 2012)
  • K082010 — STRYKER DISPOSABLE CRANIAL PERFORATOR BIT (December 29, 2008)
  • K082637 — CRANIAL PERFORATOR (December 22, 2008)
  • K073336 — CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 (January 4, 2008)
  • K071931 — CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 (October 22, 2007)
  • K982991 — ANSPACH ACCESS CRANIAL PERFORATOR (October 21, 1998)