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510(k) K925360

ES-100 POWER SYSTEM, ES-100 SERIES by Elekta Instruments, Inc. — Product Code GEY

K925360 is an FDA 510(k) premarket notification submitted by Elekta Instruments, Inc. for the device "ES-100 POWER SYSTEM, ES-100 SERIES". The FDA issued a decision of Substantially Equivalent on September 7, 1993. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. Elekta Instruments, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1993
Date Received
October 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Elekta Instruments, Inc.

  • K983678 — ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE (January 15, 1999)
  • K955064 — SPETZLER TI 100 ANEURYSM CLIP (October 17, 1996)
  • K941823 — LEKSELL NEURO GENERATOR AND ACCESSORIES (March 22, 1996)
  • K946165 — CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM (May 23, 1995)
  • K943468 — LEKSELL SURGIPLAN (January 20, 1995)
  • K932261 — ES-100 ACCESSORIES (January 7, 1994)
  • K914808 — LEKSELL GAMMAPLAN (LGP) (January 23, 1992)

Other clearances for product code GEY

  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (March 28, 2002)
  • K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (November 14, 2001)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K971941 — AQUA SPRAY (August 14, 1997)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)
  • K971268 — BONE & MARROW CLLECTION SYSTEM (July 3, 1997)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K970530 — ANSPACH LUBRICATING SYSTEM II (May 5, 1997)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)

FDA data resources