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510(k) K912651

AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM by Stackhouse Assoc. — Product Code FYD

K912651 is an FDA 510(k) premarket notification submitted by Stackhouse Assoc. for the device "AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 8, 1991. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Stackhouse Assoc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1991
Date Received
June 17, 1991
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 Stackhouse Assoc.

  • K910515 — FREEDOM MARK III SURGICAL HELMET SYSTEM (May 6, 1991)
  • K874512 — MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM (January 27, 1988)
  • K872935 — ANTI-INFECTION SHIELD (November 9, 1987)
  • K790877 — BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO (May 23, 1979)

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