Product code FYD— General, Plastic Surgery
8Q10 Surclear Smoke Plume Evacuation System
- Classification name
- Apparatus, Exhaust, Surgical
- Device class
- Class 2
- Regulation
- 21 CFR 878.5070
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 75
- First cleared
- Most recent
Market context for product code FYD
FDA has cleared devices under product code FYD between 1985 and 2024, filed by 47 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2015
- 2014
- 2009
- 2006
- 2005
- 2004
- 2002
- 2001
Top applicants under product code FYD
Recent clearances under product code FYD
- K240127 — PlumeSafe X5 Smoke Management System
- K233789 — 8Q10 Surclear Smoke Plume Evacuation System
- K213068 — Medline Smoke Evacuation Shroud
- K202944 — NEBULAE SRS Laparoscopic Surgical Smoke Removal System
- K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
- K192035 — EvaQMax Smoke Evacuation System
- K191328 — Megadyne Foot Switch
- K182224 — SafeAir Smoke Evacuator compact
- K173108 — Smoklean
- K163659 — Crystal Vision
- K142335 — RapidVac Smoke Evacuator System
- K131402 — VISICLEAR SMOKE EVACUATION SYSTEM
- K091139 — CONMED AER DEFENSE SMOKE EVACUATOR
- K053464 — SERVICE MANAGER SM40SE
- K052797 — LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM
- K043494 — MASTEL LASER CLEAN ROOM, MODEL EBS-100
- K032400 — LAFACI
- K020510 — SMOKE EVACUATION HOSES/TUBING
- K012991 — NEPTUNE WASTE MANAGEMENT STSTEM
- K003840 — CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES
- K001082 — STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
- K000904 — PENADAPT 10
- K990037 — NEPTUNE WASTE MANAGEMENT SYSTEM
- K992361 — PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
- K983298 — BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
- K983333 — BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
- K983364 — BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
- K991167 — STERIS SMOKE EVACUATION SYSTEM
- K980915 — VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
- K973610 — SKYVAL
- K970352 — SMARTVAC SMOKE EVACUATION SYSTEM
- K952981 — FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC
- K943226 — BUFFALO FILTER REPLACEMENT FILTER #BSPF030
- K943227 — BUFFALO FILTER REPLACEMENT FILTER #BSUCF03
- K940266 — BEI MEDICAL SYSTEMS' SMOKE EVACUATOR
- K935439 — SNJ SMOKE EVACUATION SUCTION WAND
- K932230 — CRYSTAL VISION AND ACCESSORIES
- K930043 — ACU-EVAC
- K930058 — BUFFALO FILTER REPLACEMENT FILTER #BPTU100
- K930062 — BUFFALO FILTER REPLACEMENT FILTER #BST300UL
- K930167 — REUSABLE TOWEL AND GOWN PACKS
- K930434 — PLUMEMASTER SMOKE EVACUATION SYSTEM
- K930060 — BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO
- K930063 — BUFFALO FILTER REPLACEMENT FILTER #BCULPA
- K930064 — BUFFALO FILTER REPLACEMENT FILTER #BCR0030
- K930065 — BUFFALO FILTER REPLACEMENT FILTER #BCR0043
- K930066 — BUFFALO FILTER REPLACEMENT FILTER #BCCHAR
- K930041 — VICROSAFE 6 AND VICROSAFE 12
- K930040 — BUFFALO FILTER REPLACEMENT #BLFS-101/103
- K930061 — BUFFALO FILTER REPLACEMENT FILTER BST312PF
- K930059 — BUFFALO FILTER REPLACEMENT FILTER #BSTM300
- K930450 — BUFFALO FILTER REPLACEMENT FILTER #BILF-100
- K924731 — PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEM
- K924732 — PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM
- K920629 — QUINEVAC II
- K923799 — SMOKE EATER
- K922555 — ENVIROMATE(TM) SMOKE EVACUATION SYSTEM
- K920209 — CRF CHARCOAL CANISTER REPLACEMENT FILTER
- K920210 — SRH-678 VACCUUM TUBING
- K920371 — HPM REPLACEMENT ULPA FILTER MODEL UF001
- K914118 — I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR
- K912612 — SMOKE/ODOR EVACUATOR #757
- K912347 — BIPURE 1000
- K913036 — PLUME MASTER
- K912853 — PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM)
- K912422 — SURG/ASSIST MODEL SA-1
- K911154 — SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200
- K912651 — AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM
- K902611 — I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR
- K896822 — SURGISMOKE
- K894038 — PLUME-AWAY SMOKE EVACUATION SYSTEM
- K894765 — SHARPLAN SMOKE EVACUATION UNIT, MODEL 100
- K880890 — THE S.A.F.E. SYSTEM
- K874512 — MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM
- K844087 — XANAR MODEL XSE-300 SMOKE EVACULATER
Data sourced from openFDA. This site is unofficial and independent of the FDA.