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510(k) K073336

CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 by Codman & Shurtleff, Inc. — Product Code HBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2008
Date Received
November 28, 2007
Clearance Type
Special
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 Codman & Shurtleff, Inc.

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  • K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) (October 3, 2017)
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  • K171747 — MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stre (July 14, 2017)
  • K171653 — YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up (July 3, 2017)
  • K162563 — YOGA Microcatheter (January 5, 2017)
  • K162437 — Codman EDS3 CSF External Drainage System (October 28, 2016)

Other clearances for product code HBF

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  • 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)
  • 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)