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510(k) K121253

MERIDIAN CRANIAL PERFORATOR by Adeor Medical Technologies GmbH — Product Code HBF

K121253 is an FDA 510(k) premarket notification submitted by Adeor Medical Technologies GmbH for the device "MERIDIAN CRANIAL PERFORATOR". The FDA issued a decision of Substantially Equivalent on Jul 17, 2012. The device falls under product code HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered)), a Class II device regulated under 21 CFR 882.4305.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 17, 2012
Date Received
Apr 25, 2012
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

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  • K213228 — NeuroLine Disposable Cranial Perforator with Hudson end (Jun 20, 2022)
  • K183581 — Codman Disposable Perforators (Jan 20, 2019)
  • K141455 — EASYDRILL AUTOSTOP CRANIAL PERFORATOR (Mar 16, 2015)
  • K082010 — STRYKER DISPOSABLE CRANIAL PERFORATOR BIT (Dec 29, 2008)
  • K082637 — CRANIAL PERFORATOR (Dec 22, 2008)
  • K073336 — CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 (Jan 4, 2008)
  • K071931 — CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 (Oct 22, 2007)
  • K032970 — ACRA-CUT XPRESS 120 (Dec 8, 2003)

FDA data resources