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510(k) K002484

EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL by Electro Medical Systems SA — Product Code JDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2000
Date Received
August 14, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Sonic And Accessory/Attachment
Device Class
Class II
Regulation Number
888.4580
Review Panel
OR
Submission Type

Other clearances by Electro Medical Systems SA

  • K022328 — EMS PIEZON MASTER 600 (August 13, 2002)
  • K022119 — EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE (July 25, 2002)
  • K012445 — EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) (August 24, 2001)
  • K991857 — AIRFLOW HANDY (October 7, 1999)
  • K992251 — SWISS LITHOCLAST MULTIPURPOSE PROBE (July 27, 1999)
  • K965203 — RADX SYSTEM (March 17, 1997)
  • K963285 — EMS SWISS LITHOCLAST LITHOTRIPTER (February 13, 1997)
  • K964111 — LITHOVAC SUCTION/ASPIRATION PROBE (December 16, 1996)
  • K953026 — MINIPIEZON (August 28, 1995)
  • K951531 — SWISS LITHOCLAST LITHOTRIPTER (August 24, 1995)

Other clearances for product code JDX

  • K201274 — Ultrasonic Osteotomy Surgical System (February 19, 2021)
  • K172464 — XD880A Ultrasonic Osteotomy Surgical System (April 24, 2018)
  • K163610 — PIEZOTOME M+, PIEZOTOME M+ Handpiece (May 19, 2017)
  • K153743 — PIEZOSURGERY PLUS (May 25, 2016)
  • K132848 — PIEZOSURGERY FLEX (November 29, 2013)
  • K100410 — PIEZOELECTRIC SYSTEM (April 28, 2010)
  • K093805 — OSCAR 3 (February 19, 2010)
  • K083284 — PIEZOSURGERY MEDICAL (April 8, 2009)
  • K083830 — OSCAR BONE RESECTOR (March 20, 2009)
  • K072961 — LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (December 19, 2007)