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510(k) K952323

MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES by Mist, Inc. — Product Code JOS

K952323 is an FDA 510(k) premarket notification submitted by Mist, Inc. for the device "MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES". The FDA issued a decision of Substantially Equivalent on June 23, 1995. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Mist, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1995
Date Received
May 18, 1995
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 Mist, Inc.

  • K970937 — MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM) (September 26, 1997)
  • K971150 — MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE (September 23, 1997)
  • K952290 — MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED D (June 23, 1995)
  • K951648 — MIST ENDOSCOPIC NEEDLES (May 12, 1995)
  • K951692 — MIST ENDOSCOPIC PROBES (May 3, 1995)
  • K951480 — MIST TROCARS (May 3, 1995)
  • K951481 — MIST ENDOSCOPIC CANNULAS (May 3, 1995)

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)

FDA data resources