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510(k) K082010

STRYKER DISPOSABLE CRANIAL PERFORATOR BIT by Stryker Ireland Ltd., Instruments Division — Product Code HBF

K082010 is an FDA 510(k) premarket notification submitted by Stryker Ireland Ltd., Instruments Division for the device "STRYKER DISPOSABLE CRANIAL PERFORATOR BIT". The FDA issued a decision of Substantially Equivalent on December 29, 2008. The device falls under product code HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered)), a Class II device regulated under 21 CFR 882.4305. Stryker Ireland Ltd., Instruments Division has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2008
Date Received
July 15, 2008
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 Stryker Ireland Ltd., Instruments Division

  • K073633 — STRYKER ESSX MICRODEBRIDER SYSTEM (August 26, 2008)

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)
  • 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)
  • K982991 — ANSPACH ACCESS CRANIAL PERFORATOR (October 21, 1998)

FDA data resources