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510(k) K930043

ACU-EVAC by Acuderm, Inc. — Product Code FYD

K930043 is an FDA 510(k) premarket notification submitted by Acuderm, Inc. for the device "ACU-EVAC". The FDA issued a decision of Substantially Equivalent on February 9, 1994. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Acuderm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1994
Date Received
January 5, 1993
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 Acuderm, Inc.

  • K933516 — ACU-E PUNCH (March 24, 1994)
  • K933265 — ACU-DISPO-CE(TM) (March 7, 1994)
  • K933137 — ACU-SUTURE KIT (February 22, 1994)
  • K933866 — ACU-HEMOSTATIC RING (December 1, 1993)
  • K915000 — ACU-GUARD (January 27, 1992)
  • K891334 — ACU-CURETTE (April 11, 1989)
  • K874024 — ACU-MICRO-NEEDLE (November 23, 1987)
  • K854877 — ACU-SYRINGE W/WO NEEDLES (February 19, 1986)
  • K832583 — SABOURAUD DEXTROSE AGAR (September 12, 1983)
  • K832582 — MYCOSEL AGAR (September 12, 1983)

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