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510(k) K874719

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

K874719 is an FDA 510(k) premarket notification submitted by Alternative Design Systems, Inc. for the device "STRATUM ESU". The FDA issued a decision of Substantially Equivalent on Feb 16, 1988. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Alternative Design Systems, Inc. has 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 16, 1988
Date Received
Nov 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
510(k)

Other clearances by Alternative Design Systems, Inc.

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

Other clearances for product code JOS

  • K161600 — Resection Electrodes (Sep 6, 2016)
  • K050923 — LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE… (May 18, 2005)
  • K012684 — REPROCESSED ELECTROSURGICAL ELECTRODE (Jan 18, 2002)
  • K011515 — MEDLINE GROUNDING PAD (Jul 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 (Feb 10, 2000)
  • K991830 — CAPSULAR SHRINKAGE ELECTRODE (Aug 20, 1999)
  • K974735 — STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED… (Jun 24, 1998)
  • K973554 — VALLEY FORGE BIPOLAR BALL TIP ELECTRODE (Dec 19, 1997)

FDA data resources