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510(k) K902611

I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR by I.C Medical, Inc. — Product Code FYD

K902611 is an FDA 510(k) premarket notification submitted by I.C Medical, Inc. for the device "I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR". The FDA issued a decision of Substantially Equivalent on August 17, 1990. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. I.C Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1990
Date Received
June 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

Other clearances by I.C Medical, Inc.

  • K163659 — Crystal Vision (October 30, 2017)
  • K160160 — Non-Telescopic PenEvac (April 5, 2016)
  • K003840 — CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES (February 1, 2001)
  • K960492 — SI CONTROLLER MODEL SI 500 (December 23, 1996)
  • K961616 — TELESCOPING PENEVAC (MODIFICATION) (May 28, 1996)
  • K955166 — PENEVAC SI. (April 11, 1996)
  • K955020 — PENEVAC ABC HANDPIECE (April 9, 1996)
  • K953418 — ELECTROCAUTERY SHROUD (October 7, 1995)
  • K954088 — TELESCOPING PENEVAC (September 22, 1995)
  • K932230 — CRYSTAL VISION AND ACCESSORIES (February 18, 1994)

Other clearances for product code FYD

  • K240127 — PlumeSafe X5 Smoke Management System (August 5, 2024)
  • K233789 — 8Q10 Surclear Smoke Plume Evacuation System (April 10, 2024)
  • K213068 — Medline Smoke Evacuation Shroud (January 3, 2022)
  • K202944 — NEBULAE SRS Laparoscopic Surgical Smoke Removal System (March 25, 2021)
  • K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect (June 26, 2020)
  • K192035 — EvaQMax Smoke Evacuation System (August 29, 2019)
  • K191328 — Megadyne Foot Switch (July 26, 2019)
  • K182224 — SafeAir Smoke Evacuator compact (February 7, 2019)
  • K173108 — Smoklean (May 18, 2018)
  • K163659 — Crystal Vision (October 30, 2017)

FDA data resources