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510(k) K913036

PLUME MASTER by Sorex Medical — Product Code FYD

K913036 is an FDA 510(k) premarket notification submitted by Sorex Medical for the device "PLUME MASTER". The FDA issued a decision of Substantially Equivalent on September 6, 1991. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Sorex Medical has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1991
Date Received
July 9, 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 Sorex Medical

  • K923843 — FOGLESS (March 25, 1994)
  • K911070 — PICC-FIX (July 5, 1991)
  • K911150 — SOREX SAFE-AIR (June 28, 1991)
  • K910315 — PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K (April 5, 1991)
  • K905572 — EDLICH WOUND MANAGEMENT TRAY (March 12, 1991)
  • K903740 — TRACH-EZE (December 6, 1990)
  • K902410 — MEDICAL PROCEDURE TRAY (November 20, 1990)
  • K885136 — GRAFT GUARD (February 6, 1989)

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