Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- CAHFilter, Bacterial, Breathing-Circuit2Product Code
- MAJCatheter, Percutaneous, Intraspinal, Short Term2Product Code
- OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)1Product Code
- LEYSet, Oral Administration2Product Code
- NIHDisinfectant, Subsystem, Water Purification2Product Code
- NIIDisinfectant, Dialysate Delivery System2Product Code
- FLJUnit, Airflow, Laminar2Product Code
- FRTUnit, Isolation, Surgical2Product Code
- FYDApparatus, Exhaust, Surgical2Product Code
- K240127PlumeSafe X5 Smoke Management System2Cleared 510(K)
- K2337898Q10 Surclear Smoke Plume Evacuation System2Cleared 510(K)
- K213068Medline Smoke Evacuation Shroud2Cleared 510(K)
- K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal System2Cleared 510(K)
- K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor2Cleared 510(K)
- K192035EvaQMax Smoke Evacuation System2Cleared 510(K)
- K191328Megadyne Foot Switch2Cleared 510(K)
- K182224SafeAir Smoke Evacuator compact2Cleared 510(K)
- K173108Smoklean2Cleared 510(K)
- K163659Crystal Vision2Cleared 510(K)
- K142335RapidVac Smoke Evacuator System2Cleared 510(K)
- K131402VISICLEAR SMOKE EVACUATION SYSTEM2Cleared 510(K)
- K091139CONMED AER DEFENSE SMOKE EVACUATOR2Cleared 510(K)
- K053464SERVICE MANAGER SM40SE2Cleared 510(K)
- K052797LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM2Cleared 510(K)
- K043494MASTEL LASER CLEAN ROOM, MODEL EBS-1002Cleared 510(K)
- K032400LAFACI2Cleared 510(K)
- K020510SMOKE EVACUATION HOSES/TUBING2Cleared 510(K)
- K012991NEPTUNE WASTE MANAGEMENT STSTEM2Cleared 510(K)
- K003840CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES2Cleared 510(K)
- K001082STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 31002Cleared 510(K)
- K000904PENADAPT 102Cleared 510(K)
- K990037NEPTUNE WASTE MANAGEMENT SYSTEM2Cleared 510(K)
- K992361PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF12Cleared 510(K)
- K983298BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF2Cleared 510(K)
- K983364BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO18012Cleared 510(K)
- K983333BUFFALO FILTER VIROSAFE HRF- #VSHRFO12Cleared 510(K)
- K991167STERIS SMOKE EVACUATION SYSTEM2Cleared 510(K)
- K980915VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM2Cleared 510(K)
- K973610SKYVAL2Cleared 510(K)
- K970352SMARTVAC SMOKE EVACUATION SYSTEM2Cleared 510(K)
- K952981FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC2Cleared 510(K)
- K943226BUFFALO FILTER REPLACEMENT FILTER #BSPF0302Cleared 510(K)
- K943227BUFFALO FILTER REPLACEMENT FILTER #BSUCF032Cleared 510(K)
- K940266BEI MEDICAL SYSTEMS' SMOKE EVACUATOR2Cleared 510(K)
- K935439SNJ SMOKE EVACUATION SUCTION WAND2Cleared 510(K)
- K932230CRYSTAL VISION AND ACCESSORIES2Cleared 510(K)
- K930043ACU-EVAC2Cleared 510(K)
- K930167REUSABLE TOWEL AND GOWN PACKS2Cleared 510(K)
- K930062BUFFALO FILTER REPLACEMENT FILTER #BST300UL2Cleared 510(K)
- K930058BUFFALO FILTER REPLACEMENT FILTER #BPTU1002Cleared 510(K)
- K930434PLUMEMASTER SMOKE EVACUATION SYSTEM2Cleared 510(K)
- K930064BUFFALO FILTER REPLACEMENT FILTER #BCR00302Cleared 510(K)
- K930060BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO2Cleared 510(K)
- K930063BUFFALO FILTER REPLACEMENT FILTER #BCULPA2Cleared 510(K)
- K930065BUFFALO FILTER REPLACEMENT FILTER #BCR00432Cleared 510(K)
- K930066BUFFALO FILTER REPLACEMENT FILTER #BCCHAR2Cleared 510(K)
- K930041VICROSAFE 6 AND VICROSAFE 122Cleared 510(K)
- K930061BUFFALO FILTER REPLACEMENT FILTER BST312PF2Cleared 510(K)
- K930040BUFFALO FILTER REPLACEMENT #BLFS-101/1032Cleared 510(K)
- K930059BUFFALO FILTER REPLACEMENT FILTER #BSTM3002Cleared 510(K)
- K930450BUFFALO FILTER REPLACEMENT FILTER #BILF-1002Cleared 510(K)
- K924731PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEM2Cleared 510(K)
- K924732PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM2Cleared 510(K)
- K920629QUINEVAC II2Cleared 510(K)
- K923799SMOKE EATER2Cleared 510(K)
- K922555ENVIROMATE(TM) SMOKE EVACUATION SYSTEM2Cleared 510(K)
- K920210SRH-678 VACCUUM TUBING2Cleared 510(K)
- K920209CRF CHARCOAL CANISTER REPLACEMENT FILTER2Cleared 510(K)
- K920371HPM REPLACEMENT ULPA FILTER MODEL UF0012Cleared 510(K)
- K914118I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR2Cleared 510(K)
- K912612SMOKE/ODOR EVACUATOR #7572Cleared 510(K)
- K912347BIPURE 10002Cleared 510(K)
- K913036PLUME MASTER2Cleared 510(K)
- K912853PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM)2Cleared 510(K)
- K912422SURG/ASSIST MODEL SA-12Cleared 510(K)
- K911154SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-2002Cleared 510(K)
- K912651AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM2Cleared 510(K)
- K902611I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR2Cleared 510(K)
- K896822SURGISMOKE2Cleared 510(K)
- K894765SHARPLAN SMOKE EVACUATION UNIT, MODEL 1002Cleared 510(K)
- K894038PLUME-AWAY SMOKE EVACUATION SYSTEM2Cleared 510(K)
- K880890THE S.A.F.E. SYSTEM2Cleared 510(K)
- K874512MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM2Cleared 510(K)
- K844087XANAR MODEL XSE-300 SMOKE EVACULATER2Cleared 510(K)
- ORCAir Filter Portable Apparatus2Product Code
- QGIAir-Handling Apparatus Accessory1Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BIPURE 1000
- Page Type
- Cleared 510(K)
- 510(k) Number
- K912347
- 510(k) Type
- Traditional
- Applicant
- LASER ENGINEERING, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/23/1991
- Days to Decision
- 118 days
- Submission Type
- Statement