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510(k) K213228

NeuroLine Disposable Cranial Perforator with Hudson end by Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. — Product Code HBF

K213228 is an FDA 510(k) premarket notification submitted by Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. for the device "NeuroLine Disposable Cranial Perforator with Hudson end". The FDA issued a decision of Substantially Equivalent on June 20, 2022. 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
June 20, 2022
Date Received
September 29, 2021
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 for product code HBF

  • K231403 — evoDrill Cranial Perforator (March 6, 2024)
  • 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)
  • K982991 — ANSPACH ACCESS CRANIAL PERFORATOR (October 21, 1998)

FDA data resources