Home / 510(k) Clearances / K874719

510(k) K874719

STRATUM ESU by Alternative Design Systems, Inc. — Product Code JOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1988
Date Received
November 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Alternative Design Systems, Inc.

  • K874697 — STRATUM D (December 15, 1987)
  • K854757 — 5000 SERIES ECG ELECTRODES (April 23, 1986)
  • K853633 — TENS CONDUCTIVE MEDIA PAD (December 3, 1985)
  • K852515 — ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR (June 24, 1985)
  • K830778 — MONITORING KIT AMK-1 (October 14, 1983)

Other clearances for product code JOS

  • K161600 — Resection Electrodes (September 6, 2016)
  • K050923 — LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTI (May 18, 2005)
  • K012684 — REPROCESSED ELECTROSURGICAL ELECTRODE (January 18, 2002)
  • K011515 — MEDLINE GROUNDING PAD (July 13, 2001)
  • K003403 — ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 (May 7, 2001)
  • K000333 — STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, (May 3, 2000)
  • K993885 — ULTRABLATOR ELECTRODE (February 10, 2000)
  • K991830 — CAPSULAR SHRINKAGE ELECTRODE (August 20, 1999)
  • K974735 — STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLA (June 24, 1998)
  • K973554 — VALLEY FORGE BIPOLAR BALL TIP ELECTRODE (December 19, 1997)