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510(k) K930434

PLUMEMASTER SMOKE EVACUATION SYSTEM by Sorenson Laboratories, Inc. — Product Code FYD

K930434 is an FDA 510(k) premarket notification submitted by Sorenson Laboratories, Inc. for the device "PLUMEMASTER SMOKE EVACUATION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 16, 1993. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Sorenson Laboratories, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1993
Date Received
January 26, 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 Sorenson Laboratories, Inc.

  • K931356 — SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR (September 7, 1993)
  • K920597 — HANDI-LASE CO2 SURGICAL LASER INSTRUMENT (June 4, 1992)

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