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510(k) K983298

BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF by Buffalo Filter Co., Inc. — Product Code FYD

K983298 is an FDA 510(k) premarket notification submitted by Buffalo Filter Co., Inc. for the device "BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF". The FDA issued a decision of Substantially Equivalent on August 16, 1999. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Buffalo Filter Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1999
Date Received
September 21, 1998
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 Buffalo Filter Co., Inc.

  • K131402 — VISICLEAR SMOKE EVACUATION SYSTEM (March 3, 2014)
  • K000904 — PENADAPT 10 (June 8, 2000)
  • K983364 — BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 (August 11, 1999)
  • K983333 — BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 (August 11, 1999)
  • K943226 — BUFFALO FILTER REPLACEMENT FILTER #BSPF030 (July 10, 1995)
  • K943227 — BUFFALO FILTER REPLACEMENT FILTER #BSUCF03 (July 7, 1995)
  • K930067 — BUFFALO FILTER SURGICAL MASK (November 30, 1993)
  • K930058 — BUFFALO FILTER REPLACEMENT FILTER #BPTU100 (November 30, 1993)
  • K930062 — BUFFALO FILTER REPLACEMENT FILTER #BST300UL (November 30, 1993)
  • K930063 — BUFFALO FILTER REPLACEMENT FILTER #BCULPA (November 12, 1993)

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