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510(k) K073336

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

K073336 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231". The FDA issued a decision of Substantially Equivalent on January 4, 2008. The device falls under product code HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered)), a Class II device regulated under 21 CFR 882.4305. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K193380 — CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (July 20, 2020)
  • K191237 — CERENOVUS Large Bore Catheter (November 8, 2019)
  • K173192 — CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLin (November 8, 2017)
  • K172537 — Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage Sy (October 16, 2017)
  • K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) (October 3, 2017)
  • K171862 — GALAXY G3 Mini Microcoil Delivery System (September 25, 2017)
  • 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

  • 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)
  • 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