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510(k) K833266

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

K833266 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 December 29, 1983. The device falls under product code HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered)), a Class II device regulated under 21 CFR 882.4305. Acra Cut, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1983
Date Received
September 21, 1983
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.

  • K032970 — ACRA-CUT XPRESS 120 (December 8, 2003)
  • 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)

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)
  • K032970 — ACRA-CUT XPRESS 120 (December 8, 2003)

FDA data resources