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510(k) K233789

8Q10 Surclear Smoke Plume Evacuation System by Surnic Corporation — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2024
Date Received
November 28, 2023
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 Surnic Corporation

  • K203522 — Surn5 Electrosurgical Argon Beam Generator and Accessories (February 22, 2021)

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  • 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)
  • K142335 — RapidVac Smoke Evacuator System (January 14, 2015)