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510(k) K935584

MEDNEXT BUR by Mednext, Inc. — Product Code EQJ

K935584 is an FDA 510(k) premarket notification submitted by Mednext, Inc. for the device "MEDNEXT BUR". The FDA issued a decision of Substantially Equivalent on February 22, 1994. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. Mednext, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1994
Date Received
November 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Ear, Nose And Throat
Device Class
Class I
Regulation Number
874.4140
Review Panel
EN
Submission Type

Other clearances by Mednext, Inc.

  • K983092 — TRITON HUDSON CHUCK ATTACHMENT (November 6, 1998)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K970023 — MEDNEXT SURGICAL BUR (February 28, 1997)
  • K943108 — MEDNEXT MICRO-DRILL (August 17, 1994)
  • K935861 — MEDNEXT BUR (May 3, 1994)
  • K926547 — MEDNEXT 1000 BONE DISSECTING SYSTEM (July 22, 1993)

Other clearances for product code EQJ

  • K161514 — Precision Thin Reciprocating Blade, 0.010in. (January 17, 2017)
  • K041985 — XPS CURVED BUR (August 12, 2004)
  • K974232 — ESSENTIAL SHAVER SYSTEM (January 12, 1998)
  • K960853 — ACE SYSTEM (April 3, 1996)
  • K955704 — TREBAY MICRODEBRIDER SYSTEM (January 30, 1996)
  • K955294 — SOF - ABRASION BUR (December 22, 1995)
  • K954912 — TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (December 6, 1995)
  • K953370 — KARL STORZ ENT SHAVER (September 6, 1995)
  • K950337 — KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL (August 23, 1995)
  • K952609 — REDI DRILL DRILL SYSTEM (July 31, 1995)

FDA data resources