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510(k) K183581

Codman Disposable Perforators by Integra Lifesciences Corp. — Product Code HBF

K183581 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "Codman Disposable Perforators". The FDA issued a decision of Substantially Equivalent on January 20, 2019. The device falls under product code HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered)), a Class II device regulated under 21 CFR 882.4305. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2019
Date Received
December 21, 2018
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 Integra Lifesciences Corp.

  • K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable (January 11, 2019)
  • K182265 — CodMan Certas Plus Programmable Valve (November 20, 2018)
  • K181902 — Codman Certas Plus Electronic Tool Kit (October 25, 2018)
  • K150682 — CUSA Excel+ (December 18, 2015)
  • K150428 — Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) K (April 16, 2015)
  • K131184 — INTEGRA LICOX PTO2 MONITOR (August 30, 2013)
  • K092227 — JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS (February 17, 2010)
  • K092395 — OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM (November 19, 2009)
  • K081635 — INTEGRA MESHED BILAYER WOUND MATRIX (December 4, 2008)
  • K081401 — MAYFIELD MR/X-RAY SKULL CLAMP (October 8, 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)
  • 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