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
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- FLGCleaner, Ultrasonic, Medical Instrument1Product Code
- FLHWasher Of Body Waste Receptacles1Product Code
- FLICabinet, Ethylene-Oxide Gas Aerator2Product Code
- BRTRestraint, Patient, Conductive1Product Code
- BYYTube, Aspirating, Flexible, Connecting2Product Code
- BYZTrap, Sterile Specimen2Product Code
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)2Product Code
- CBDBottle, Collection, Breathing System (Calibrated)2Product Code
- FLESterilizer, Steam2Product Code
- FLFSterilizer, Ethylene-Oxide Gas2Product Code
- FMADepressor, Tongue, Non-Surgical1Product Code
- FMCPatient Examination Glove1Product Code
- FMEGown, Examination1Product Code
- FMLChair, Blood Donor1Product Code
- FMPProtector, Skin Pressure1Product Code
- FMQRestraint, Protective1Product Code
- FMRDevice, Transfer, Patient, Manual1Product Code
- FMWCover, Mattress (Medical Purposes)1Product Code
- FNPUrinal1Product Code
- FNSRing Cutter1Product Code
- FNYBasin, Emesis1Product Code
- FOABoard, Cardiopulmonary1Product Code
- FOBBedpan1Product Code
- FOXStand, Infusion1Product Code
- FPFBottle, Hot/Cold Water1Product Code
- FPOStretcher, Wheeled2Product Code
- FPPStretcher, Hand-Carried1Product Code
- FPSBoard, Bed1Product Code
- FRAPurifier, Air, Ultraviolet, Medical2Product Code
- FRGWrap, Sterilization2Product Code
- FRJChair, Geriatric1Product Code
- FRKChair, Examination And Treatment1Product Code
- FRZDevice, Patient Transfer, Powered2Product Code
- GAZTubing, Noninvasive2Product Code
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered2Product Code
- JOKScissors, Medical, Disposable1Product Code
- JOLCatheter And Tip, Suction2Product Code
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2Product Code
- K241927Synthes Graphic Case & Tray System2Cleared 510(K)
- K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)2Cleared 510(K)
- K242023Microdent Sterilization Cassette2Cleared 510(K)
- K243317NUVENTUS NV.C™ Surgical Cassette and Tray2Cleared 510(K)
- K242834System 9 Sterile Battery Container2Cleared 510(K)
- K243128Klockner Kits2Cleared 510(K)
- K241492Guided Surgery Kit Cases2Cleared 510(K)
- K240898SteriTite rigid reusable sterilization container with MediTray Products2Cleared 510(K)
- K241050CrossRoads Modular Tray System2Cleared 510(K)
- K241378S.I.N. Instrument Kits2Cleared 510(K)
- K231291Perforated Baskets2Cleared 510(K)
- K233578BAHADIR STERILIZATION CONTAINERS2Cleared 510(K)
- K231144Washtrays2Cleared 510(K)
- K233264Anthogyr INTEGRAL Guided Surgery Cassettes2Cleared 510(K)
- K233222Aygün Sterilization Container Systems2Cleared 510(K)
- K231604Instrument Case2Cleared 510(K)
- K231501PRO-LITE Sterilization Tray2Cleared 510(K)
- K230680Anthogyr Surgical Cassettes2Cleared 510(K)
- K230804Complement Kit Cases2Cleared 510(K)
- K231219NobelZygoma PureSet™ Tray2Cleared 510(K)
- K222640Sweden & Martina Surgical Trays2Cleared 510(K)
- K223662Neodent Implant System - Helix Short Surgical Kit Cases2Cleared 510(K)
- K223672Instrument Case P13409042Cleared 510(K)
- K214041Aesculap AICON Container2Cleared 510(K)
- K222514S.I.N. Instrument Kits2Cleared 510(K)
- K221492SteriTite Container System with MediTray Parts2Cleared 510(K)
- K222005S.I.N. Instrument Kits2Cleared 510(K)
- K222328SteriCUBE® Multiple Tray Sterilization Systems2Cleared 510(K)
- K220791Surgical and Prosthetic Trays2Cleared 510(K)
- K212711SteriTite Container System with MediTray Products2Cleared 510(K)
- K214051Neodent Implant System-Helix NGM Compact Surgical Kit Cases2Cleared 510(K)
- K212281Surgical Trays2Cleared 510(K)
- K210923Southern Implants Instrument Trays2Cleared 510(K)
- K203177Sterisystem Dry-Base Instrument Tray2Cleared 510(K)
- K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device2Cleared 510(K)
- K203468TCAT TKA Instrument Tray2Cleared 510(K)
- K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray2Cleared 510(K)
- K210836InstruSafe Instrument Protection System2Cleared 510(K)
- K212068Biotech Dental Kits2Cleared 510(K)
- K212404S.I.N. Instrument Kits2Cleared 510(K)
- K212396UroLift System Rigid Retrieval Kit Sterilization Tray2Cleared 510(K)
- K203492Instrument tray, for semi-rigid ureteroscope2Cleared 510(K)
- K203753Straumann Surgical Cassettes2Cleared 510(K)
- K203198KARL STORZ Metal Sterilization Trays2Cleared 510(K)
- K211007EZ-TRAXTM Persona Knee Containment Device2Cleared 510(K)
- K203572Karl Storz Radel Sterilization Trays2Cleared 510(K)
- K201878ST-Z52Cleared 510(K)
- K203618Neodent EasyGuide Kit Cases2Cleared 510(K)
- K201533Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes2Cleared 510(K)
- K201945KARL STORZ UDEL Sterilization Trays2Cleared 510(K)
- K201412BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit2Cleared 510(K)
- K202524Standard Sterilizable Tray2Cleared 510(K)
- K202268CrossRoads Tray System2Cleared 510(K)
- K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device2Cleared 510(K)
- K202515NUVO Implant System – NUVO Instrument Kit Cases2Cleared 510(K)
- K182084Sweden & Martina Surgical Tray (Model ZSHORTY-INT)2Cleared 510(K)
- K202105OsteoMed ExtremiFix Mini & Small System Tray2Cleared 510(K)
- K201688S.I.N. Instrument Kits2Cleared 510(K)
- K200858Mini Sterilizable Tray2Cleared 510(K)
- K193066Steripack cases and Tray Systems2Cleared 510(K)
- K193603Benesta Medical Sterilization Tray2Cleared 510(K)
- K192781UroLift System Procedure Kit Sterilization Tray2Cleared 510(K)
- K200632TCAT TKA Instrument Tray Set2Cleared 510(K)
- K192056JJ Series Container System2Cleared 510(K)
- K193582SterilContainer S2 System2Cleared 510(K)
- K191566Avinent Surgical Tray2Cleared 510(K)
- K192487EZ-TRAX Containment Device2Cleared 510(K)
- K190665Neodent Instrument Kit Cases2Cleared 510(K)
- K192670Neodent Instrument Kit Cases2Cleared 510(K)
- K191522Straumann Modular Cassette2Cleared 510(K)
- K181845Pivot System Sterilization case2Cleared 510(K)
- K190541MTS225 and MTS300 Multiple Tray Sterilization Systems2Cleared 510(K)
- K190840Medtronic Transportation / Sterilization Cassettes2Cleared 510(K)
- K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate2Cleared 510(K)
- K182414Aesculap® SterilContainer(TM) S2 System2Cleared 510(K)
- K190667Sonopet iQ Sterilization Tray2Cleared 510(K)
- K181933DePuy Synthes Sterilization Container System2Cleared 510(K)
- K183701Stryker ChestShield Sterilization Tray System2Cleared 510(K)
- K182865Neodent Instruments Kits2Cleared 510(K)
- K180127TCAT (R) THA Instrument Tray Set2Cleared 510(K)
- K183402PRO-LITE Sterilization Tray2Cleared 510(K)
- K182052Omni Instrument Tray2Cleared 510(K)
- K183139Endoscope Sterilization Tray2Cleared 510(K)
- K183301PRO-LITE Sterilization Tray2Cleared 510(K)
- K182032SterilContainer S System2Cleared 510(K)
- K180528InstruSafe(R) Sterilization Container2Cleared 510(K)
- K173642KLOCKNER SURGICAL BOX2Cleared 510(K)
- K180964Endoscope Sterilization Tray2Cleared 510(K)
- K181075PureSet Tray2Cleared 510(K)
- K180915Sonicision Reusable Sterilization Tray2Cleared 510(K)
- K180791Straumann BLX Surgical Cassette2Cleared 510(K)
- K173259Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories2Cleared 510(K)
- K173391OsteoMed QuickFix Hybrid MMF Sterilization Tray2Cleared 510(K)
- K173615Stryker Universal Select Sterilization Tray System2Cleared 510(K)
- K171713Neodent Instrument Kits2Cleared 510(K)
- K171692Instrument basket, for EndoEYE2Cleared 510(K)
- K172755PRO-LITE Sterilization Trays2Cleared 510(K)
- K171520SteriZign Signatur Device Protection System2Cleared 510(K)
- K163600Kit Boxes and Kit Plates2Cleared 510(K)
- K172292SALUS - Hygiene Instrument Reprocessing Container2Cleared 510(K)
- K172850SterilContainer with PrimeLine Pro Lid2Cleared 510(K)
- K170226iTotal Family Reusable Instrument Tray2Cleared 510(K)
- K170640Endoscope Sterilization Tray2Cleared 510(K)
- K170939Supplemental Instrument Trays2Cleared 510(K)
- K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator2Cleared 510(K)
- K162815SterilContainer S System2Cleared 510(K)
- K160730Instrument kits2Cleared 510(K)
- K162063Steri-Cassette and Steri-Cage Sterilization Packaging System2Cleared 510(K)
- K163279Medtronic Transportation/Sterilization Cassettes2Cleared 510(K)
- K160574K3PRO SURGICAL TRAY2Cleared 510(K)
- K162600Jewel Precision Reusable Rigid Sterilization Container System2Cleared 510(K)
- K160912Sterilization Tray2Cleared 510(K)
- K161347Signia sterilization tray2Cleared 510(K)
- K152745ReNew Sterilization Trays(Catalog #3708 and #3709)2Cleared 510(K)
- K152111Symmetry Surgical Quad-Lock Container System2Cleared 510(K)
- K152969ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY2Cleared 510(K)
- K153554Genesis Low Temperature Reusable Rigid Container System2Cleared 510(K)
- K152743M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)2Cleared 510(K)
- K151594Ellipse Supplemental Instrument Trays2Cleared 510(K)
- K152241Medtronic Transportation/Sterilization Cassettes2Cleared 510(K)
- K151450Endoscope Sterilization Tray2Cleared 510(K)
- K152951Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray2Cleared 510(K)
- K141854INSTRUMENT CASSETTE (EFCCL1-F)2Cleared 510(K)
- K152014MTS300 Multiple Tray Sterilization System2Cleared 510(K)
- K151347MIS Spine Frame Instrument Case2Cleared 510(K)
- K151242SterilContainer S2Cleared 510(K)
- K143579NuVasive Sterilization Trays2Cleared 510(K)
- K151166Instru-Safe Instrument Protection System2Cleared 510(K)
- K143729SterilContainer S2Cleared 510(K)
- K142970SterilContainer S System2Cleared 510(K)
- K150540Instru-Safe Instrument Protection System2Cleared 510(K)
- K142768Instru-Safe Instrument Protection System2Cleared 510(K)
- K142519InterActive Complete Surgical Tray2Cleared 510(K)
- K142937Endoscope Sterilization Tray2Cleared 510(K)
- K142109STERILUCENT STERILIZATION CONTAINER SYSTEM2Cleared 510(K)
- K142529Genesis Reusable Rigid Container System2Cleared 510(K)
- K142630Instru-Safe Instrument Protection System2Cleared 510(K)
- K141513INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM2Cleared 510(K)
- K141616STERILIZATION CASSETTE2Cleared 510(K)
- K140850GENESIS REUSABLE RIGID CONTAINER SYSTEM2Cleared 510(K)
- K130720SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM2Cleared 510(K)
- K131407BAHADIR STERILIZATION TRAYS2Cleared 510(K)
- K133942ENDOSCOPE STERILIZATION TRAY2Cleared 510(K)
- K140494V-PRO STERILIZATION TRAY/ STERILIZATION MAT2Cleared 510(K)
- K140289INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM2Cleared 510(K)
- K133116VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC2Cleared 510(K)
- K133015INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM2Cleared 510(K)
- K131455RESTORE MODULAR STERILIZATION TRAY SYSTEM2Cleared 510(K)
- K131170SONICISION STERILIZATION TRAY2Cleared 510(K)
- K123234ERMIS STERILIZATION CONTAINER SYSTEM2Cleared 510(K)
- K130532IDRIVE ULTRA STERILIZATION TRAY2Cleared 510(K)
- K121904GYNECOLOGY STERILIZATION TRAY2Cleared 510(K)
- K123175DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-43432Cleared 510(K)
- K121280MYOSURE INTRUMENT TRAY2Cleared 510(K)
- K122818OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE2Cleared 510(K)
- K120947THS INSTRUMENT TRAY2Cleared 510(K)
- K112087TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS2Cleared 510(K)
- K110898S.C.O.R.E.S. UNIT2Cleared 510(K)
- K120474GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY2Cleared 510(K)
- K112090BAHADIR STERILIZATION TRAYS2Cleared 510(K)
- K112671STERILCONTAINER SYSTEM2Cleared 510(K)
- K112535GENESIS REUSABLE RIGID CONTAINER SYSTEM2Cleared 510(K)
- K112536SONICISION STERILIZATION TRAY2Cleared 510(K)
- K120117CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM2Cleared 510(K)
- K110748OLYMPUS INSTRUMENT TRAY2Cleared 510(K)
- K110682STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS2Cleared 510(K)
- K110500STAT-MAT MINOR2Cleared 510(K)
- K102970GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT2Cleared 510(K)
- K103226STERILIZATION MATS2Cleared 510(K)
- K103213FINESS ENDOSCOPE STERILIZATION TRAY2Cleared 510(K)
- K102544SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY2Cleared 510(K)
- K102103SKELETAL DYNAMICS STERILIZATION TRAYS2Cleared 510(K)
- K102122SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 722024282Cleared 510(K)
- K092745VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU2Cleared 510(K)
- K102146BAHADIR STERILIZATION TRAYS2Cleared 510(K)
- K092551SMITH & NEPHEW INSTRUMENT TRAYS2Cleared 510(K)
- K100887VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY2Cleared 510(K)
- K101653MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES2Cleared 510(K)
- K093800ROBINSON MEDSURG QUICKSCREW RACK2Cleared 510(K)
- K091720SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM2Cleared 510(K)
- K092437CODMAN STERILIZATION CONTAINERS2Cleared 510(K)
- K092414CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM2Cleared 510(K)
- K091806POGO SCREW INSTRUMENTATION TRAY2Cleared 510(K)
- K092682GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS2Cleared 510(K)
- K090818KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS2Cleared 510(K)
- K091627SMITH & NEPHEW INSTRUMENT TRAYS2Cleared 510(K)
- K090560CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS2Cleared 510(K)
- K090371VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM2Cleared 510(K)
- K090562SMITH & NEPHEW INSTRUMENT TRAYS2Cleared 510(K)
- K071783VERSAPOD (TM) INSTRUMENT TRAYS2Cleared 510(K)
- K080531CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY2Cleared 510(K)
- K073551SMITH & NEPHEW INSTRUMENT TRAYS2Cleared 510(K)
- K073168AESCULAP PRIMELINE CONTAINER LTD.2Cleared 510(K)
- K072211INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS2Cleared 510(K)
- K072563MILTEX RIGID CONTAINER SYSTEMS2Cleared 510(K)
- K070765VIS-U-ALL II SELF SEAL POUCH2Cleared 510(K)
- K070769VHP 136 TRAY2Cleared 510(K)
- K070428MEDICOM SELF-SEALING STERILIZATION POUCH2Cleared 510(K)
- K061033MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)2Cleared 510(K)
- K052567ONE TRAY SEALED STERILIZATION CONTAINER2Cleared 510(K)
- K051242WINNER SELF SEAL STERILIZATION POUCH2Cleared 510(K)
- K051157INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS2Cleared 510(K)
- K050570MILTEX RIGID STERILIZATION CONTAINER SYSTEM2Cleared 510(K)
- K040223POLYVAC INSTRUMENT DELIVERY SYSTEM2Cleared 510(K)
- K042062PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE2Cleared 510(K)
- K033222OLYMPUS STERILIZATION TRAYS2Cleared 510(K)
- K032445THE ULTRA SYSTEM2Cleared 510(K)
- K032813THE ULTRA SYSTEM SP2Cleared 510(K)
- K032119PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS2Cleared 510(K)
- K012105POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM2Cleared 510(K)
- K993764MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH2Cleared 510(K)
- K972719CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS2Cleared 510(K)
- K980065C/T MED-SYSTEMS CASSETTE SYSTEM2Cleared 510(K)
- K973827KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION2Cleared 510(K)
- K973981SAFEPASS STERILIZATION POUCH2Cleared 510(K)
- K973440REXAM FRACTURE RESISTANT POUCH2Cleared 510(K)
- K960738STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)2Cleared 510(K)
- K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE2Cleared 510(K)
- K962600REXAM SELF-SEAL TYVEK POUCH2Cleared 510(K)
- K953068OXBORO-MEDICAL FOAM INSTRUMENT HOLDER2Cleared 510(K)
- K952787FOAM INSTRUMENT GUARD2Cleared 510(K)
- K954185RE-BAG MULTI-USE POUCH, LARGE & SMALL2Cleared 510(K)
- K954090AUTO SUTURE* STERILIZATION TRAY**2Cleared 510(K)
- K953829SAFE-T-SEAL2Cleared 510(K)
- K953749MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS2Cleared 510(K)
- K953776STERIKING STERILIZATION POUCHES & ROLLS2Cleared 510(K)
- K951295STERRAD STERILIZATION POUCH2Cleared 510(K)
- K951590ASSURE, SELF-SEALING STERILIZATION POUCH2Cleared 510(K)
- K935755THE ULTRA2Cleared 510(K)
- K941327CROSSTEX SELF-SEALING STERILIZATION POUCH2Cleared 510(K)
- K944864PRIMED RIGID CONTAINER SYSTEM2Cleared 510(K)
- K945055HARKEN ASSURE SELF-SEAL STERILIZATION POUCH2Cleared 510(K)
- K940807SEE-THRU SELF SEALING STERILIZATION POUCH2Cleared 510(K)
- K932086AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH2Cleared 510(K)
- K932088AUTOPAK STERILIZATION POUCH2Cleared 510(K)
- K922440STERIKING, SEE & PEEL2Cleared 510(K)
- K932056DEFEND SELF-SEALING STERILIZATION POUCH2Cleared 510(K)
- K933729ASSURE SELF SEALING STERILIZATION POUCH2Cleared 510(K)
- K934252RPPI STERILIZATION BAGS2Cleared 510(K)
- K930072STERITUBE2Cleared 510(K)
- K933560BARRIER PLASTIC PACKAGING (MODIFICATION)2Cleared 510(K)
- K935739SHAVE PREP TRAY2Cleared 510(K)
- K924118PROPAK2Cleared 510(K)
- K893802PROVIEW SELF-SEALING STERILIZATION POUCH2Cleared 510(K)
- K891210POCKETED WRAPS #3009 A,B,C2Cleared 510(K)
- K891983CAM-WRAP(TM) NEW STERILIZATION PROCEDURE2Cleared 510(K)
- K891214DENTAL SURGICAL WRAP #3007 A,B,C2Cleared 510(K)
- K891213SURGICAL INSTRUMENT POUCH #M1022Cleared 510(K)
- K891215FAST WRAP #M 1012Cleared 510(K)
- K884041MASTER-GUARD2Cleared 510(K)
- K860528THE KEYMED FIBERSCOPE STERILIZATION CASE2Cleared 510(K)
- K854063MICROVASIVE SILICONE SPRAY2Cleared 510(K)
- K834558CK10000 SERIES POUCH & BAGS ETC.2Cleared 510(K)
- K832128SELF-SEAL STERILIZATION POUCHES2Cleared 510(K)
- K831588INSTRUMENT GUARD CAPSULE2Cleared 510(K)
- K831165DUSTCOVERS/STERILITY MAINTENANCE COVERS2Cleared 510(K)
- K830961EASY BREATHER HEADER BAGS2Cleared 510(K)
- K821332DUSTCOVERS &/OR STERILITY MAINT. COVERS2Cleared 510(K)
- K810469STERILEDGE SELF SEAL POUCH2Cleared 510(K)
- K791412DISPOSABLE INSTRUMENT TRAY PAD2Cleared 510(K)
- K790547PRO-TAB2Cleared 510(K)
- K782144DISPOSABLE SURGICAL INSTRUMENT TIP2Cleared 510(K)
- K781699EAGLE PAC/VISIBLE SEAL2Cleared 510(K)
- K771124INSTRUMENT TRAY PAD2Cleared 510(K)
- K771123SURGICAL INSTRUMENT PROTECTOR2Cleared 510(K)
- K770912TIPROTECTOR2Cleared 510(K)
- K770590SURGI-KIT2Cleared 510(K)
- K760320PROTECTOR, SURGICAL INSTRUMENT2Cleared 510(K)
- KDPRegulator, Vacuum2Product Code
- KDQBottle, Collection, Vacuum2Product Code
- KIACover, Cast1Product Code
- KMEBedding, Disposable, Medical1Product Code
- KMGPurifier, Water, Ultraviolet, Medical2Product Code
- KMHSterilizer, Dry Heat2Product Code
- KMJLubricant, Patient1Product Code
- KMNChair And Table, Medical1Product Code
- KXFApplicator, Absorbent Tipped, Non-Sterile1Product Code
- KXGApplicator, Absorbent Tipped, Sterile1Product Code
- KYRBag, Ice1Product Code
- KYSInsoles, Medical1Product Code
- KYTLight, Examination, Medical, Battery Powered1Product Code
- KYWContainer, Liquid Medication, Graduated1Product Code
- KYXDispenser, Liquid Medication1Product Code
- KYZSyringe, Irrigating (Non Dental)1Product Code
- KZADevice, Vein Location, Liquid Crystal1Product Code
- KZFDevice, Medical Examination, Ac Powered1Product Code
- KZHIntroducer, Syringe Needle2Product Code
- LBJDevice, Vein Stabilization1Product Code
- LDSDevice, Pasteurization, Hot Water2Product Code
- LRJDisinfectant, Medical Devices1Product Code
- LYYLatex Patient Examination Glove1Product Code
- LYZVinyl Patient Examination Glove1Product Code
- LZAPolymer Patient Examination Glove1Product Code
- LZBFinger Cot1Product Code
- LZCPatient Examination Glove, Specialty1Product Code
- MDZCleaners, Medical Devices2Product Code
- MECDisinfector, Medical Devices2Product Code
- MEDSterilant, Medical Devices2Product Code
- MKBDevice, Germicidal, Ultraviolet2Product Code
- MLRSterilizer, Chemical2Product Code
- MMSLubricant, Vaginal, Patient1Product Code
- MTVSharps Needle Destruction Device2Product Code
- NRVImplantable Radio Frequency Transponder System2Product Code
- NZDStretcher, Patient Restraint1Product Code
- NZHMedication Management System, Remote2Product Code
- NZJRespirator, N95, For Use By The General Public In Public Health Medical Emergencies2Product Code
- OHYPill Crusher/Cutter1Product Code
- OIGPowder-Free Guayle Rubber Examination Glove1Product Code
- PEQAccessories To Examination Light1Product Code
- OPCPowder-Free Polychloroprene Patient Examination Glove1Product Code
- OPHRadiation Attenuating Medical Glove1Product Code
- OPIAntimicrobial Medical Glove1Product Code
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs1Product Code
- ORWN95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies2Product Code
- OSZAntimicrobial Keyboard2Product Code
- OUGMedical Device Data System1Product Code
- OVYLiquid Chemical Processing System2Product Code
- OYSPatient Bed With Canopy/Restraints1Product Code
- PADChest Drainage Kit2Product Code
- PECSterilizer Automated Loading System2Product Code
- PJJTwo Or More Sterilant Sterilizer2Product Code
- PWMAdmission Kit (Patient Utensil)1Product Code
- PYQRfid Chip For Dental Appliance2Product Code
- PWPBlood Borne Pathogen Response Kit1Product Code
- PWSChemotherapy Administration Kit1Product Code
- PWTChemotherapy Spill Clean-Up Kit1Product Code
- PWUClean-Up Kit1Product Code
- PWVDelivery Room Apparel Kit1Product Code
- PWZMid-Stream Collection Kit1Product Code
- PXAOral Administration Set1Product Code
- PXCPersonal Protection Kit1Product Code
- PXDPrep Kit1Product Code
- PXFSitz Bath Kit1Product Code
- PXGSpill Kit1Product Code
- PXMVomitus Clean-Up Kit1Product Code
- QDOFentanyl And Other Opioid Protection Glove1Product Code
- QTVMattress And Bed Deck Cover (Medical Purposes)1Product Code
- 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
HARKEN ASSURE SELF-SEAL STERILIZATION POUCH
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K945055
- 510(k) Type
- Traditional
- Applicant
- HARKEN PRODUCTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/14/1994
- Days to Decision
- 61 days
- Submission Type
- Summary