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
- K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)2Cleared 510(K)
- K241565Sterilization Package/Reel2Cleared 510(K)
- K243431Medicom Sterilization Pouch and Reel2Cleared 510(K)
- K242898Sterilization Pouches and Reels2Cleared 510(K)
- K240438CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)2Cleared 510(K)
- K242839Safe Secure Sterilization Pouches and Rolls2Cleared 510(K)
- K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)2Cleared 510(K)
- K241123Perpak™ Sterilization Tyvek Pouch2Cleared 510(K)
- K234132Medline Reusable Sterilization Wrappers2Cleared 510(K)
- K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap2Cleared 510(K)
- K240330HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)2Cleared 510(K)
- K240862Medicom Sterilization Wrap2Cleared 510(K)
- K232625Steriking® Pouch for Robotic Instruments2Cleared 510(K)
- K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)2Cleared 510(K)
- K233262Dukal SMS Sterilization Wrap2Cleared 510(K)
- K230137Reliance® Fusion Sterilization Wraps2Cleared 510(K)
- K231999Steriking® LT-Blueline Pouches with Tyvek®2Cleared 510(K)
- K231996Steriking® LT-Blueline Pouches with Tyvek®2Cleared 510(K)
- K223600Sterilization Wrap2Cleared 510(K)
- K231500Vis-U-All Low Temperature Sterilization Pouches2Cleared 510(K)
- K223025Tyvek Roll with CI for STERLINK Sterilizer2Cleared 510(K)
- K222151Sterilization Wrap2Cleared 510(K)
- K221875Sterilization Pouch and Roll2Cleared 510(K)
- K221379Steriking LT-Blueline Pouches with Tyvek2Cleared 510(K)
- K221377SteriKing LT-Blueline Pouches with Tyvek2Cleared 510(K)
- K220365Gemini Sterilization Wrap2Cleared 510(K)
- K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays2Cleared 510(K)
- K191131Solidence Multipockets2Cleared 510(K)
- K214007HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap2Cleared 510(K)
- K221016Steriking Packaging for Medical Devices2Cleared 510(K)
- K213907CareGUARD Sterilization Wrap2Cleared 510(K)
- K220133Sterilization Wraps2Cleared 510(K)
- K210810Steiking Packaging for Medical Devices2Cleared 510(K)
- K212338SterileRight sterilization pouch and roll2Cleared 510(K)
- K212198Tyvek(R) Roll with CI for STERLINKTM Sterilizer2Cleared 510(K)
- K202593Turbett Instrument Pod2Cleared 510(K)
- K202462SIGMA Sterilization Pouch and Roll2Cleared 510(K)
- K200336Tyvek Sterilization Pouches with Chevron Seal2Cleared 510(K)
- K200335Sterisheet Sterilization Wrap2Cleared 510(K)
- K200240Turbett Instrument Pod2Cleared 510(K)
- K193561Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch2Cleared 510(K)
- K192641Gemini Titan Sterilization Wrap2Cleared 510(K)
- K192147Halyard ONE-STEP* Sterilization Wrap2Cleared 510(K)
- K182184Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)2Cleared 510(K)
- K183356Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch2Cleared 510(K)
- K181957Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted2Cleared 510(K)
- K182656JAMBRO Single Core A Sterilization wrap2Cleared 510(K)
- K181959HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)2Cleared 510(K)
- K183401Vis-U-All Low Temperature Sterilization Pouch/Tubing2Cleared 510(K)
- K183297Vis-U-All Low Temperature Sterilization Pouch/Tubing2Cleared 510(K)
- K180139Safe Secure Sterilization Pouches and Rolls2Cleared 510(K)
- K181174Cardinal Health Sterilization Wrap2Cleared 510(K)
- K172280BH Sterilization Pouch2Cleared 510(K)
- K180672Sterilization Pouch/Roll Made with Tyvek2Cleared 510(K)
- K180661SIGMA Sterilization Pouch and Roll2Cleared 510(K)
- K172749Vis-U-All Low Temperature Sterilization Pouch/Tubing2Cleared 510(K)
- K170437Sterisheet Sterilization Wrap2Cleared 510(K)
- K170429Tyvek Sterilization Pouches with Chevron Seal2Cleared 510(K)
- K162362PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator2Cleared 510(K)
- K172207Standard Supreme Sterilization Wrapper2Cleared 510(K)
- K171533Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap2Cleared 510(K)
- K162993Gemini Sterilization Wrap2Cleared 510(K)
- K162258Self Sealing Sterilization Pouches2Cleared 510(K)
- K161910Cardinal Health Sterilization Wrap2Cleared 510(K)
- K161415SteriTite Containers System & MediTray Products2Cleared 510(K)
- K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator2Cleared 510(K)
- K162162Barrier Supreme Sterilization Wrapper2Cleared 510(K)
- K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators2Cleared 510(K)
- K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap2Cleared 510(K)
- K160908Vis-U-All Low Temperature Sterilization Pouch/Tubing2Cleared 510(K)
- K152564Gemini Sterilization Wrap2Cleared 510(K)
- K152458Gemini Bonded Sterilization Wrap2Cleared 510(K)
- K152669PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)2Cleared 510(K)
- K153025Turbett Surgical Container2Cleared 510(K)
- K151445Cardinal Health Sterilization Wrap2Cleared 510(K)
- K152291Sterisheet Sterilization Wrap2Cleared 510(K)
- K150698Gemini Sterilization Wrap2Cleared 510(K)
- K152058Tyvek Sterilization Pouches with Chevron Seal2Cleared 510(K)
- K151788Cardinal Health Sterilization Wrap2Cleared 510(K)
- K143117Wire Sterilization Package with Indicators2Cleared 510(K)
- K143637U&U Sterilization Pouch and Roll2Cleared 510(K)
- K143147Gemini Bonded Sterilization Wrap2Cleared 510(K)
- K143053KIMGUARD ONE-STEP Sterilization Wrap2Cleared 510(K)
- K141826FLASHPAK STERILIZATION CONTAINER SYSTEM2Cleared 510(K)
- K133838STERILIZATION POUCH/ROLL MADE WITH TYVEK2Cleared 510(K)
- K142782KIMGUARD ONE-STEP Sterilization Wrap2Cleared 510(K)
- K141693Tyvek® Pouch/Roll with STERRAD® Chemical Indicator2Cleared 510(K)
- K141712KIMGUARD ONE STEP STERILIZATION WRAP2Cleared 510(K)
- K141412STERILUCENT SELF-SEAL STERILIZATION POUCH2Cleared 510(K)
- K140963KIMGUARD SMART-FOLD STERILIZATION WRAP2Cleared 510(K)
- K141612KIMGUARD ONE-STEP STERILIZATION WRAP2Cleared 510(K)
- K141071KIMGUARD ONE-STEP STERILIZATION WRAP2Cleared 510(K)
- K140487VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING2Cleared 510(K)
- K123162U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL2Cleared 510(K)
- K132060DURABLUE STERILIZATION WRAP2Cleared 510(K)
- K113806KIMGUARD ONE STEP STERILIZATION WRAP2Cleared 510(K)
- K130927DURABLUE STERILIZATION WRAP2Cleared 510(K)
- K123289DURABLUE STERILIZATION WRAP2Cleared 510(K)
- K113353GEMINI STERILZATION WRAP2Cleared 510(K)
- K123857DURABLUE STERILIZATION WRAP2Cleared 510(K)
- K122507DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION2Cleared 510(K)
- K110954ARJORAD STERILE WRAP2Cleared 510(K)
- K113776FLASHPAK2Cleared 510(K)
- K112805KIMGUARD ONE-STEP STERILIZATION WRAP2Cleared 510(K)
- K120658DURABLUE STERILIZATION WRAP2Cleared 510(K)
- K120542CARDINAL HEALTH DURABLUE STERILIZATION WRAP2Cleared 510(K)
- K112591SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS2Cleared 510(K)
- K112904STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS2Cleared 510(K)
- K112918DURABLUE STERILIZATION (AMSCO V-PRO) WRAP2Cleared 510(K)
- K112300KIMGUARD SMART-FOLD* STERILIZATION WRAP2Cleared 510(K)
- K112283DURA BLUE STERILIZATION WRAP2Cleared 510(K)
- K112211DURA BLUE STERILIZATION WRAP2Cleared 510(K)
- K102158SIGMA STERILIZATION POUCH & ROLL2Cleared 510(K)
- K110867STERI-DENT, STERI-SURE2Cleared 510(K)
- K103210TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS2Cleared 510(K)
- K10286484E SERIES SINGLE PLY WRAPPER2Cleared 510(K)
- K102783HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS2Cleared 510(K)
- K093493AESCULAP STERILCONTAINER S2Cleared 510(K)
- K093649AESCULAP STERILCONTAINER S2Cleared 510(K)
- K090068STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS2Cleared 510(K)
- K092167KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC6002Cleared 510(K)
- K091685KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC6002Cleared 510(K)
- K082554KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC6002Cleared 510(K)
- K082177KIMGUARD ONE-STEP STERILIZATION WRAP2Cleared 510(K)
- K080558STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS2Cleared 510(K)
- K080198TSO3 OZONE STERILIZATION WRAP2Cleared 510(K)
- K071886SELF SEAL STERILIZATION POUCH2Cleared 510(K)
- K071087VIS-U-ALL II HEAT-SEAL POUCH AND TUBING2Cleared 510(K)
- K062704STERILIZATION POUCH WITH INDICATORS2Cleared 510(K)
- K062100ARJOWRAP 47/100 AND 47/882Cleared 510(K)
- K062510AESCULAP STERILCONTAINER SYSTEM2Cleared 510(K)
- K052992CONMED LINVATEC INSTRUMENT STERILIZATION TRAY2Cleared 510(K)
- K052665GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES2Cleared 510(K)
- K053389AESCULAP STERILCONTAINER SYSTEM2Cleared 510(K)
- K041096WAGNER STERISET STERILIZATION CONTAINER2Cleared 510(K)
- K041623REUSABLE STERILCONTAINER FILTER MODEL #JK0902Cleared 510(K)
- K040865AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER2Cleared 510(K)
- K042580TIDI BRAND STERILIZATION WRAP2Cleared 510(K)
- K040707PACKAGING TRAY AND COMPONENTS2Cleared 510(K)
- K022978STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS2Cleared 510(K)
- K031022PROTEC-TOP, STERIDENT, BENTO2Cleared 510(K)
- K023614STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM2Cleared 510(K)
- K023658STERILIZATION CASES AND TRAYS2Cleared 510(K)
- K030853STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI2Cleared 510(K)
- K023025SELF SEAL STERILIZATION POUCH2Cleared 510(K)
- K013003APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER2Cleared 510(K)
- K012931GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM2Cleared 510(K)
- K013715RE-USABLE STERILIZATION POUCH / BAG2Cleared 510(K)
- K993535METAPAK MULTI-PURPOSE INSTRUMENT TRAY2Cleared 510(K)
- K010825MEDLINE STERISET STERILIZATION CONTAINER2Cleared 510(K)
- K002968MEDLINE STERILIZATION WRAP2Cleared 510(K)
- K983299ALLEGIANCE GENESIS CONTAINER SYSTEM2Cleared 510(K)
- K993871BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP2Cleared 510(K)
- K991023STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL2Cleared 510(K)
- K993835PARAPOST SYSTEM STERILIZABLE ORGANIZER2Cleared 510(K)
- K993255BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE2Cleared 510(K)
- K983719BIOSHIELD EXPRESS STERILIZATION WRAP2Cleared 510(K)
- K990761TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE2Cleared 510(K)
- K990567GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH2Cleared 510(K)
- K990300SUPRASHIELD EXPRESS STERILIZATION WRAP2Cleared 510(K)
- K983223DENTAL STERLIZATION TRAY/CASSETTE2Cleared 510(K)
- K974638STERITITE SEALED CONTAINERS MODEL SCO4Q2Cleared 510(K)
- K972138CARR RIGID CONTAINER SYSTEM2Cleared 510(K)
- K971483SECURE-WRAP (TM) STERILIZATION WRAP2Cleared 510(K)
- K964256CYGNUS INSTRUMENT PROTECTORS2Cleared 510(K)
- K962605PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)2Cleared 510(K)
- K970152BIOPSY TRAY2Cleared 510(K)
- K961227JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY2Cleared 510(K)
- K960211CPR TOTAL KNEE PACK2Cleared 510(K)
- K960213CPR TOTAL HIP PACK2Cleared 510(K)
- K960206CPR DRESSING CHANGE TRAY2Cleared 510(K)
- K960210CPR ORTHO HAND PACK2Cleared 510(K)
- K960208CPR BASIC SET-UP TRAY2Cleared 510(K)
- K960238CPR SUTURE REMOVAL KIT2Cleared 510(K)
- K960520LACERATION TRAY2Cleared 510(K)
- K960204G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY2Cleared 510(K)
- K960207CPR LACERATION TRAY2Cleared 510(K)
- K960141G.E. STERILE, STANDARD BIOPSY TRAY2Cleared 510(K)
- K960201G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY2Cleared 510(K)
- K960202G.E. STERILE PUNCTURE TRAY2Cleared 510(K)
- K955688RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY2Cleared 510(K)
- K955686RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY2Cleared 510(K)
- K955678RNS STERILE DISPOSABLE PUNCTURE TRAY2Cleared 510(K)
- K955658LACERATION TRAY2Cleared 510(K)
- K953678STERIMED STERIZATION WRAPPER (NON-STERILE)2Cleared 510(K)
- K951704NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION2Cleared 510(K)
- K946019SURGICLA INSTRUMENT KIT2Cleared 510(K)
- K950438SAFEDWEEL DRESSING CHANGE TRAY2Cleared 510(K)
- K950850GENT-L-KARE LACERATION TRAYS2Cleared 510(K)
- K943653MAMMOCORE BIOPSY TRAY2Cleared 510(K)
- K944881SKIN SCRUB TRAY2Cleared 510(K)
- K944854STERISURE STERILIZATION WRAP2Cleared 510(K)
- K943090SUTURE REMOVAL TRAYS2Cleared 510(K)
- K941645BIOPSY TRAY2Cleared 510(K)
- K931875AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE2Cleared 510(K)
- K931874RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE2Cleared 510(K)
- K941542ORION CENTRAL LINE DRESSING CHANGE TRAY2Cleared 510(K)
- K942000BURN DRESSING TRAY2Cleared 510(K)
- K941467WOUND DRESSING KIT2Cleared 510(K)
- K941471CENTRAL LINE DRESSING CHANGE TRAY2Cleared 510(K)
- K941468DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY2Cleared 510(K)
- K941466SURGICAL INSTRUMENTS KIT2Cleared 510(K)
- K933550HYDRASPUN M STERILIZATION WRAP2Cleared 510(K)
- K934031STERILE CENTRAL LINE DRESSING TRAY2Cleared 510(K)
- K935238ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY2Cleared 510(K)
- K935742SKIN SCRUB TRAY2Cleared 510(K)
- K935682LACERATION TRAY2Cleared 510(K)
- K935681INCISION/DRAINAGE TRAY2Cleared 510(K)
- K935683SUTURE REMOVAL TRAY2Cleared 510(K)
- K935685TRACHEOSTOMY CARE TRAY2Cleared 510(K)
- K935622CUSTOM PLASTIC PACKS2Cleared 510(K)
- K931669CARAPACE DEBRIDEMENT KITS2Cleared 510(K)
- K931202STERILIZATION WRAP-STERISHEET2Cleared 510(K)
- K933151CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM2Cleared 510(K)
- K932036LACERATION TRAY2Cleared 510(K)
- K923408WRAPPEL T2Cleared 510(K)
- K922845BASIC DRESSING CHANGE TRAY SMP 102A2Cleared 510(K)
- K921243CONVERTORS STERILIZATION WRAP2Cleared 510(K)
- K920480DRESSING CHANG & WOUND MANAGEMENT2Cleared 510(K)
- K921490DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP2Cleared 510(K)
- K920339DRESSING CHANGE TRAY2Cleared 510(K)
- K914932SUTURE REMOVAL KIT2Cleared 510(K)
- K911760MONARCH STERILIZATION CONTAINER SYST, MODIFICATION2Cleared 510(K)
- K894437PEEL-VUE AUTOCLAVE/CHEMICALVE POUCH2Cleared 510(K)
- K893764STERILIZATION TRAY LINER2Cleared 510(K)
- K885019BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.2Cleared 510(K)
- K883802CARETEX CENTRAL SUPPLY WRAP2Cleared 510(K)
- K883376STERILIZATION WRAP TYPE 22,44,772Cleared 510(K)
- K881471KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP2Cleared 510(K)
- K873175CENTRAL SUPPLY ROOM WRAP2Cleared 510(K)
- K872754HEALTH-PAK/WYCOMBE CSR WRAP2Cleared 510(K)
- K871798FILM AND PAPER COMBINATION STERILIZING BAG2Cleared 510(K)
- K871202FLASHPAK CONTAINER SYSTEM2Cleared 510(K)
- K870147CARERITE & COST RITE NYLON STERILIZATION FILM2Cleared 510(K)
- K863981STERILIZATION WRAPS #620,624,648,640,636,630,6122Cleared 510(K)
- K862241STANDARD BASIN KIT CUSTOM BASIN KIT2Cleared 510(K)
- K852335STERILIZATION CONTAINER2Cleared 510(K)
- K850289MONARCH STERILIZATION CONTAINER SYSTEM2Cleared 510(K)
- K852203KIMGUARD PROCEDURE TRAY2Cleared 510(K)
- K851315ABCO INSTRUMENT PACKS & TRAYS2Cleared 510(K)
- K851340BLUE SEAL II STERILIZATION POUCH2Cleared 510(K)
- K844920CSR WRAP - CENTRAL SUPPLY ROOM WRAP FOR STERIL-2Cleared 510(K)
- K844672INSTRUTAINER2Cleared 510(K)
- K844611SINGLE BASIN SET2Cleared 510(K)
- K842644TPN/HYPERALIMENTATION TRAY2Cleared 510(K)
- K843982O.B. BASIN SET2Cleared 510(K)
- K842490SKIN SCRUB TRAY STERILE SKIN SCRUB KIT2Cleared 510(K)
- K842405DR. GOULD HAND PACK SUSTOM STERIL2Cleared 510(K)
- K842136STERILE PAN SET2Cleared 510(K)
- K841484STERILE O.R. BASIN KIT PRODUCT LINE2Cleared 510(K)
- K841123DRESSING CHANGE TRAY2Cleared 510(K)
- K841156VANTAGE E2Cleared 510(K)
- K840342PDI PREPMASTER WET PACK PATIENT PREP KIT2Cleared 510(K)
- K840344PDI PREPMASTER WET PACK MINOR PROCEDURE2Cleared 510(K)
- K840595E-Z OPEN DUST COVERS2Cleared 510(K)
- K834193JAKOBI SURG. INSTRUMENTS #2 70/712Cleared 510(K)
- K833343STERILIZATION CONTAINER2Cleared 510(K)
- K831425MDT CHEMITEST SEE-THRU BAG2Cleared 510(K)
- K830476OR PREP KIT2Cleared 510(K)
- K830739PRO-GUARD2Cleared 510(K)
- K830540RENNCO MODEL LS LIFT SEAL HEAT SEALER2Cleared 510(K)
- K830281SKIN SCRUB PREP. TRAY2Cleared 510(K)
- K823902EAGLE STERISET2Cleared 510(K)
- K823513CENTRAL SUPPLY ROOM WRAP2Cleared 510(K)
- K823223VIEW-PACK & MULTI POUCH2Cleared 510(K)
- K822931SCR WRAP2Cleared 510(K)
- K822482SURGILITE NON-WOVEN WRAP2Cleared 510(K)
- K822211STERILE HD PAN SET2Cleared 510(K)
- K821044PATIENT PREP KITS/TRAYS-STERILE2Cleared 510(K)
- K821331MEDI-SEAL STERILIZATION POUCHES & TUB2Cleared 510(K)
- K821330GAS STERILIZATION POUCHES2Cleared 510(K)
- K821482STERILE HD PAN SET2Cleared 510(K)
- K820689C.S.R. WRAPPERS2Cleared 510(K)
- K820589ECONOMY LINE OF TRAYS2Cleared 510(K)
- K820521STERILIZATION WRAP2Cleared 510(K)
- K820171SUBCLAVIAN INSERTION KIT2Cleared 510(K)
- K820302SURGIPEEL SELF-SEAL PACKAGING SYSTEM2Cleared 510(K)
- K813437PAN SET2Cleared 510(K)
- K811819BOUNDARY STERILIZATION WRAP2Cleared 510(K)
- K811670STERI-LOK DUAL PURPOSE PACKAGING/84002Cleared 510(K)
- K811247CATHETER MAINTENANCE KIT2Cleared 510(K)
- K811242DISPOSABLE STERILIZATION WRAP2Cleared 510(K)
- K810918ROLL-A-SET2Cleared 510(K)
- K810646OR/CS WRAP2Cleared 510(K)
- K803306ALOFT STERILIZATION WRAP2Cleared 510(K)
- K803294GUARDIAN STERILIZATION WRAP2Cleared 510(K)
- K802919ISO-BAC INSTRUMENT WRAP2Cleared 510(K)
- K803293GUARDIAN PEEL POUCHES2Cleared 510(K)
- K802577HYPERALIMENTATION SUBCLAVIIAN DRESS TRAY2Cleared 510(K)
- K802428PROPPER SHARPGUARD & TRAYPAD STERIL. AID2Cleared 510(K)
- K801333AMPCO DRESSING CHANGE TRAYS2Cleared 510(K)
- K801331AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS2Cleared 510(K)
- K801569VAL-U-WRAP CSR WRAP2Cleared 510(K)
- K801332AMPCO SKIN SCRUB TRAYS2Cleared 510(K)
- K800123DEXTEX II STERILIZATION WRAP2Cleared 510(K)
- K792369HYPERALIMENTATION DRESSING TRAY2Cleared 510(K)
- K791513ADAMCO DUST COVER2Cleared 510(K)
- K781981DECONTAMINATION ITEMS BAG2Cleared 510(K)
- K781980RESPIRATORY THERAPY GAS POUCH2Cleared 510(K)
- K781925POUCHES, GAS STERILIZATION2Cleared 510(K)
- K781924POUCHES AND TUBING, MEDI-SEAL2Cleared 510(K)
- K781301WRAP, STERILIZATION2Cleared 510(K)
- K780294G WRAP2Cleared 510(K)
- K780034AUTOCLAVE POUCHES&ROLLS/STEAM&GAS2Cleared 510(K)
- K771846SUOGIPEEL PACKAGING SYSTEM2Cleared 510(K)
- K770933BIO-SHIELD CSR WRAP2Cleared 510(K)
- K771348ECONOWRAP PAPER C.S.R. WRAP2Cleared 510(K)
- K771032POUCHES, PEEL OPEN, BREATHABLE2Cleared 510(K)
- K770797TRAY, CATHETERIZATION W/FOLEY, STERILE2Cleared 510(K)
- K770409STERI-STOR TM2Cleared 510(K)
- K770514STERILIZER WRAP2Cleared 510(K)
- K760662STERIL.WRAP(#221901,2,3,4,5,6,7,8,9)2Cleared 510(K)
- K760758STERILIZATION PACKAGING MATERIALS2Cleared 510(K)
- K760661STERILIZER WRAP (CAT#221831,2,3,4,5,6)2Cleared 510(K)
- 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
- 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
Tyvek(R) Roll with CI for STERLINKTM Sterilizer
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K212198
- 510(k) Type
- Traditional
- Applicant
- Plasmapp Co,.Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/22/2021
- Days to Decision
- 100 days
- Submission Type
- Summary