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510(k) K960853

ACE SYSTEM by Xomed, Inc. — Product Code EQJ

K960853 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "ACE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 3, 1996. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1996
Date Received
March 1, 1996
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 Xomed, Inc.

  • K002395 — MODEL 30 CLASSIC PNEUMATONOMETER (December 11, 2000)
  • K002987 — REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE (December 4, 2000)
  • K002828 — XPS NITRO SYSTEM (October 17, 2000)
  • K002897 — TITANIUM MIDDLE EAR PROSTHESES (October 11, 2000)
  • K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES (June 9, 2000)
  • K001148 — MEROGEL OTOLOGIC PACK (June 3, 2000)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)
  • K992855 — XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT (January 21, 2000)
  • K993582 — MODIFICATION TO LASER-SHIELD II (January 20, 2000)
  • K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (December 21, 1999)

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)
  • 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)
  • K953096 — ESSENTIAL SHAVER SYSTEM (July 28, 1995)

FDA data resources