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
- ERYDrape, Surgical, Ent2Product Code
- EYXDrape, Pure Latex Sheet, With Self-Retaining Finger Cot2Product Code
- EYYDrape, Urological, Disposable2Product Code
- FXOSuit, Surgical1Product Code
- FXPCover, Shoe, Operating-Room1Product Code
- FXXMask, Surgical2Product Code
- FXYHood, Surgical2Product Code
- FXZHelmet, Surgical1Product Code
- FYAGown, Surgical2Product Code
- FYBGown, Patient2Product Code
- FYCGown, Isolation, Surgical2Product Code
- HMTDrape, Patient, Ophthalmic2Product Code
- HMWDrape, Microscope, Ophthalmic2Product Code
- KGOSurgeon'S Gloves1Product Code
- KGQCream, Gloving, Surgeon'S1Product Code
- KGTDrape, Adhesive, Aerosol1Product Code
- KKXDrape, Surgical2Product Code
- K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial II2Cleared 510(K)
- K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)2Cleared 510(K)
- K202208BeneHold Surgical Incise Drape with CHG antimicrobial2Cleared 510(K)
- K200238ControlRad Sterile Cover2Cleared 510(K)
- K163556MediClear PreOp2Cleared 510(K)
- K133080Plus Surgical Drapes (EO Sterilized), PMDB-XXX2Cleared 510(K)
- K141324HONGYU DISPOSABLE SURGICAL DRAPES2Cleared 510(K)
- K140195SURGICAL DRAPE2Cleared 510(K)
- K1403303M STERI-DRAPE FABRIC SURGICAL DRAPES2Cleared 510(K)
- K141438WHITNEY MEDICAL SOLUTIONS ESHIELD2Cleared 510(K)
- K1402503M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE2Cleared 510(K)
- K140064SURGISLEEVE WOUND PROTECTOR2Cleared 510(K)
- K131571AVD RIGHT RADIAL DRAPE2Cleared 510(K)
- K130404TIBURON SURGICAL DRAPE2Cleared 510(K)
- K121436DAS MEDICAL EQUIPMENT DRAPES2Cleared 510(K)
- K121919SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV2Cleared 510(K)
- K122000HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER2Cleared 510(K)
- K112378COBES SURGICAL DRAPE2Cleared 510(K)
- K111458GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS2Cleared 510(K)
- K112136TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE2Cleared 510(K)
- K102861SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)2Cleared 510(K)
- K101350RADSCAN EQUIPMENT SLICKER2Cleared 510(K)
- K094016NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H2Cleared 510(K)
- K102666KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM2Cleared 510(K)
- K100991IMC SURGICAL DRAPE2Cleared 510(K)
- K101598EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)2Cleared 510(K)
- K101689EMM EQUIPMENT COVER-POLYTHYLENE2Cleared 510(K)
- K101688EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-0042Cleared 510(K)
- K093909BUSSE SURGICAL DRAPES IV2Cleared 510(K)
- K100208IMC SURGICAL DRAPE2Cleared 510(K)
- K092212BUSSE SURGICAL DRAPES III2Cleared 510(K)
- K091343MRI NEURO DRAPE2Cleared 510(K)
- K083234KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 1002Cleared 510(K)
- K083320DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE2Cleared 510(K)
- K083424BUSSE SURGICAL DRAPE2Cleared 510(K)
- K082297BUSSE SURGICAL DRAPE2Cleared 510(K)
- K080796SRI LP DRAPE2Cleared 510(K)
- K080629PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS2Cleared 510(K)
- K081476SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE2Cleared 510(K)
- K080341ENDODRAPE(TM)2Cleared 510(K)
- K071491ARROW INTERNATIONAL, INC., SURGICAL DRAPES2Cleared 510(K)
- K070432GENERAL SURGERY DRAPES2Cleared 510(K)
- K070406ENDODRAPE2Cleared 510(K)
- K062480JOYKEY SURGICAL DRAPES (STERILE)2Cleared 510(K)
- K061422SURGICAL DRAPES2Cleared 510(K)
- K061762TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N2Cleared 510(K)
- K052668OR SPECIFIC BIG CASE BACK TABLE COVER2Cleared 510(K)
- K060200MICROTEK MEDICAL WARMING DRAPE2Cleared 510(K)
- K053495EQUIPMENT SLUSH DRAPE2Cleared 510(K)
- K052833GORE-TEX NON-STERILE SURGICAL GOWNS2Cleared 510(K)
- K052395STERILE EQUIPMENT COVERS2Cleared 510(K)
- K052169IMC SURGICAL DRAPES2Cleared 510(K)
- K0430153L SURGICAL DRAPES2Cleared 510(K)
- K051625BARRIER SURGICAL DRAPES2Cleared 510(K)
- K050538IMC DRAPES2Cleared 510(K)
- K050322MICROTEK EQUIPMENT DRAPES2Cleared 510(K)
- K042977LASIK EYE DRAPE2Cleared 510(K)
- K050508HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES2Cleared 510(K)
- K042526DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX2Cleared 510(K)
- K032666MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES2Cleared 510(K)
- K042893UNDER BUTTOCKS DRAPE2Cleared 510(K)
- K041224FOOTHILLS SURGICAL DRAPES2Cleared 510(K)
- K042131PROMEDICAL SURGICAL DRAPES2Cleared 510(K)
- K042137PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS2Cleared 510(K)
- K041846SABRESOURCE DRAPE2Cleared 510(K)
- K041077IMALUX OCT PROBE GUIDE2Cleared 510(K)
- K031889ALEXIS WOUND RETRACTOR2Cleared 510(K)
- K031287STERI-DRAPE SURGICAL DRAPES2Cleared 510(K)
- K030908DEROYAL SURGICAL DRAPES BACKTABLE COVER2Cleared 510(K)
- K031131KLINIDRAPE SURGICAL DRAPES2Cleared 510(K)
- K031362LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS2Cleared 510(K)
- K030365DEROYAL DRAPES, STERILE, NON-STERILE2Cleared 510(K)
- K023419TRILAMINATE DRAPES/TIBURON2Cleared 510(K)
- K023117PRIMAGARD SURGICAL GOWNS2Cleared 510(K)
- K022868PRIMAGARD SURGICAL EQUIPMENT DRAPES2Cleared 510(K)
- K023425DRAPES WITH ABSORBENT REINFORCEMENT2Cleared 510(K)
- K023432MEDLINE ASEP PLUS SURGICAL DRAPES2Cleared 510(K)
- K021864PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)2Cleared 510(K)
- K020581COLOSHIELD COLONOSCOPY DRAPE MODEL E20002Cleared 510(K)
- K013958INDUS TEXTILES TOWEL-STERILE AND NON-STERILE2Cleared 510(K)
- K020393MASTER & FRANK SURGICAL DRAPES (STERILE)2Cleared 510(K)
- K020435WOUND PROTECTOR/RETRACTOR2Cleared 510(K)
- K012957TOWEL DRAPE, MODELS 4409, 44102Cleared 510(K)
- K012237MERTEX-PLUS REUSABLE SURGICAL DRAPE2Cleared 510(K)
- K012807MODIFICATION TO: COMPEL SURGICAL DRAPES2Cleared 510(K)
- K012168ADVANCE MEDICAL DESIGNS FLUID POUCH2Cleared 510(K)
- K011422SURGICAL DRAPES2Cleared 510(K)
- K010711ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR2Cleared 510(K)
- K000442ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX2Cleared 510(K)
- K010572BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE2Cleared 510(K)
- K003670PATIENT DRAPE, SURGICAL2Cleared 510(K)
- K002691COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE2Cleared 510(K)
- K002702NEUROTOLOGY DRAPE, MODEL TBD2Cleared 510(K)
- K002508EQUIPMENT DRAPES2Cleared 510(K)
- K001858OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE2Cleared 510(K)
- K002419SURGICAL DRAPES2Cleared 510(K)
- K001994EEI SLUSH PAN DRAPE2Cleared 510(K)
- K001667RESOLVE SURGICAL O.R. TOWELS2Cleared 510(K)
- K000906KLINIDRAPE SURGICAL DRAPES2Cleared 510(K)
- K994199VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR2Cleared 510(K)
- K000417CONVERTORS EQUIPMENT DRAPES2Cleared 510(K)
- K994211ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 6012852Cleared 510(K)
- K993795CONVERTORS SURGICAL DRAPES2Cleared 510(K)
- K991667BROADLINE OR TOWELS2Cleared 510(K)
- K990253SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 36002Cleared 510(K)
- K991548HAL SCOPE HOLDER SYSTEM2Cleared 510(K)
- K981823OPERATING ROOM TOWELS2Cleared 510(K)
- K981818CONVERTORS TRILAMINATE DRAPES2Cleared 510(K)
- K980210VARIOUS SURGICAL OR PATIENT DRAPES2Cleared 510(K)
- K974672MSI SURGICAL DRAPES2Cleared 510(K)
- K980183PROMAX SURGICAL DRAPES AND COVERS2Cleared 510(K)
- K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 06332Cleared 510(K)
- K973146MENTOR SUPER ABSORBENT DRAPE2Cleared 510(K)
- K970889ULTRASOUND TRANSDUCER DRAPE2Cleared 510(K)
- K971089OPPORTUNITY, INC. LACERATION TRAY2Cleared 510(K)
- K972187BOUFFANT CAP2Cleared 510(K)
- K970891DRAPE, SURGICAL-LATEX2Cleared 510(K)
- K971159SURGICAL DRAPES2Cleared 510(K)
- K970554CONVERTORS SMS DRAPES2Cleared 510(K)
- K970185STERILE DISPOSABLE EQUIPMENT MAGNET COVER2Cleared 510(K)
- K970722EYE TRAY2Cleared 510(K)
- K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS2Cleared 510(K)
- K963675THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE2Cleared 510(K)
- K964125CONVERTORS DRAPE MATERIAL2Cleared 510(K)
- K962205STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE2Cleared 510(K)
- K955749TEX-CARE STERILE STOCKINETTE2Cleared 510(K)
- K962003TUAT SPLATTER CONTROL SHIELD SCS-3002Cleared 510(K)
- K960803RX TEXTILES STERILE STOCKINETTE2Cleared 510(K)
- K960045ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE2Cleared 510(K)
- K954824PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE2Cleared 510(K)
- K960242CPR EYE TRAY2Cleared 510(K)
- K955872VOLMED OPERATION DRAPE2Cleared 510(K)
- K950565DEROYAL SURGICAL INSTRUMENT DRAPE2Cleared 510(K)
- K954212CONTAMINATION CONTAINMENT DRAPE2Cleared 510(K)
- K952759TOWEL PACK2Cleared 510(K)
- K953654ORS-1112Cleared 510(K)
- K933148SURGICAL DRAPE KIT2Cleared 510(K)
- K945755OREX(R) O.R EQUIPMENT DRAPES2Cleared 510(K)
- K951214STERILE EQUIPMENT COVER2Cleared 510(K)
- K950830STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP2Cleared 510(K)
- K941802OR TOWEL2Cleared 510(K)
- K946060REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI82Cleared 510(K)
- K945656THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE2Cleared 510(K)
- K945486SPLATTER CONTROL SHIELD2Cleared 510(K)
- K944859OREX SURGICAL DRAPES2Cleared 510(K)
- K944863COMPEL SURGICALDRAPES2Cleared 510(K)
- K9460243M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS2Cleared 510(K)
- K9460253M X-LARGE SHEET #7979/ #7979NS2Cleared 510(K)
- K943393CIVCO PROBE BOOT/CORD COVER2Cleared 510(K)
- K942294ASEP PLUS SURGICAL DRAPES2Cleared 510(K)
- K942228OREX O.R. TOWEL2Cleared 510(K)
- K931267CONVERTORS ISO BAC DRAPE MATERIAL2Cleared 510(K)
- K934630UNIVERSAL VIDEO/LASER ARM DRAPE2Cleared 510(K)
- K923960UPPER EXTERMITY DRAPE KIT2Cleared 510(K)
- K931143AMSCO STERILE RECOVERIES ABSORBENT TOWELS2Cleared 510(K)
- K943122SURGICAL DRAPES2Cleared 510(K)
- K941233GLOBAL SHOULDER O.R. DRAPE PACK2Cleared 510(K)
- K931146SURGICAL DRAPES, MODIFICATION2Cleared 510(K)
- K940175MEDSURG STERILE O.R. TOWELS2Cleared 510(K)
- K941302STERILE IMPERVIOUS ORTHOPEDIC STOCKINETTE2Cleared 510(K)
- K931455HEAD SHEET2Cleared 510(K)
- K931418SURGICAL DRAPE2Cleared 510(K)
- K930815ABDOMINAL / THORACIC PATIENT DRAPE2Cleared 510(K)
- K940702CONVERTORS OPTI-SORB DRAPE MATERIAL2Cleared 510(K)
- K934445STSTORZ DP5300 AND DP9502 STERILE DRAPES2Cleared 510(K)
- K924101STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE2Cleared 510(K)
- K934215CONTAIN-OR2Cleared 510(K)
- K936210NPAC2Cleared 510(K)
- K932253ARTHROBOT BI-FOLD DRAPE2Cleared 510(K)
- K931091DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 52522Cleared 510(K)
- K933382IMC CABLE/WIRE COVER2Cleared 510(K)
- K932857ABDOMINAL FLUID CONTROL POUCH, 203-301-S;ETC.2Cleared 510(K)
- K924335DRAPES2Cleared 510(K)
- K922918BARRIER SAF-TE HYDROGEL DRAPE2Cleared 510(K)
- K922962VARIOUS CAMEO MED BASIC BIOPSY TRAYS, DISPOSABLE2Cleared 510(K)
- K922961VARIOUS CAMEO MED PERCUTANEOUS SKIN PREP TRAYS,2Cleared 510(K)
- K921657VASECTOMY DRAPE2Cleared 510(K)
- K922059DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #5992Cleared 510(K)
- K920346VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL2Cleared 510(K)
- K923811COMPEL SURGICAL DRAPES2Cleared 510(K)
- K920808OB/GYN DRAPE2Cleared 510(K)
- K923688N-PAC2Cleared 510(K)
- K923798SURGICAL GOWN PACK2Cleared 510(K)
- K923283SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT2Cleared 510(K)
- K920284DRAPE UTILITY/SURGICAL STERILE DISPOSABLE2Cleared 510(K)
- K921049SURGICAL DRAPE2Cleared 510(K)
- K922828ULCER WOUND TRAY2Cleared 510(K)
- K920518E.R. SUTURE TRAY, STERILE, DISPOSABLE2Cleared 510(K)
- K921394DRESSING CHANGE TRAY, STERILE, DISPOSABLE2Cleared 510(K)
- K921204DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE2Cleared 510(K)
- K921203INCISSION & DRAINAGE TRAY2Cleared 510(K)
- K921350QUALTEX TUBE/CORD ORGANIZER2Cleared 510(K)
- K920045DURATECH HOSPITAL TOWEL2Cleared 510(K)
- K915740DISPOSABLE O.R. TOWEL, STERILE2Cleared 510(K)
- K920995BARRIER DRAPE SHEET WITH SYMETRY FABRIC2Cleared 510(K)
- K920517MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP2Cleared 510(K)
- K920340SUTURE REMOVAL KIT2Cleared 510(K)
- K920341LACERATION TRAYS2Cleared 510(K)
- K914761KAY-MED SURGICAL DEAPE/DRAP ACCESSORIES2Cleared 510(K)
- K920052HEALTH PAK TRAY SOX BARRIERS2Cleared 510(K)
- K913408STERILE PLASTIC DRAPE2Cleared 510(K)
- K913448DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE2Cleared 510(K)
- K913447DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #5992Cleared 510(K)
- K913486QUALTEX SURGICAL DRAPE, MODIFICATION2Cleared 510(K)
- K914929LACERATION TRAY2Cleared 510(K)
- K914605MULTIPLE STERILE SURGICAL DRAPE PACK2Cleared 510(K)
- K915214ARTHROSCOPY CAMERA DRAPE2Cleared 510(K)
- K914369QUALTEX MAGNETIC INSTRUMENT DRAPE2Cleared 510(K)
- K913536PRC AUTOPSY DEVICE2Cleared 510(K)
- K913506CONVERTORS SAFECARE GOWN & DRAPE MATERIAL2Cleared 510(K)
- K913382MEGA PARACENTESIS KIT2Cleared 510(K)
- K911944MEDI GUARD DENTAL BIB2Cleared 510(K)
- K913047STERILESERT(TM) CABLE AND POLE DRAPE2Cleared 510(K)
- K912947STARPAC O.R. TOWEL2Cleared 510(K)
- K911131STERILE SURGICAL GOWN PACK2Cleared 510(K)
- K904873STERILE SURGICAL PACK2Cleared 510(K)
- K912490CITATION MEDICAL SCOPE PROCEDURE PACK2Cleared 510(K)
- K911565CUSTOM PROCEDURE TRAY2Cleared 510(K)
- K911520ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE2Cleared 510(K)
- K911521ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP2Cleared 510(K)
- K912110DISPOSABLE O.R. TOWEL2Cleared 510(K)
- K912542PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS2Cleared 510(K)
- K911509MAGNA OBSTETRICAL PACKS2Cleared 510(K)
- K911510MAGNA SURGICAL PACKS2Cleared 510(K)
- K905803HALE SUN SURGICAL TOWEL OR O.R. TOWEL2Cleared 510(K)
- K911039INVOTEC EAR DRAPE2Cleared 510(K)
- K910084SURGICAL DRAPE2Cleared 510(K)
- K904957STERILE AND NON-STERILE TEXTILE PACKS2Cleared 510(K)
- K910495QUALTEX SURGICAL DRAPE2Cleared 510(K)
- K905701RICHARD-ALLAN SHEET CLIP2Cleared 510(K)
- K905466STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE2Cleared 510(K)
- K905465STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE2Cleared 510(K)
- K904694CUSTOMED ANGIODRAPE PACK FEMORAL2Cleared 510(K)
- K904693CUSTOMED CARDIOVASCULAR PACK2Cleared 510(K)
- K903117ORION STERILE OR TOWELS2Cleared 510(K)
- K904960QUALTEX SURGICAL DRAPE2Cleared 510(K)
- K905005DISPOSABLE SURGICAL TOWEL (NON-STERILE)2Cleared 510(K)
- K903346DISPOSABLE EMISSIONS BARRIER LASER DRAPE2Cleared 510(K)
- K902191CUSTOMED LAP PACK II2Cleared 510(K)
- K901705CUSTOMED CYSTO PACK II2Cleared 510(K)
- K904112STI DRAPE SHEET STYLE 19082Cleared 510(K)
- K903908REPAK SURGICAL PACKS2Cleared 510(K)
- K902715SURGICAL TOWEL2Cleared 510(K)
- K902886CUSTOMED BASIC PACK III2Cleared 510(K)
- K902885CUSTOMED BASIC PACK II2Cleared 510(K)
- K902884CUSTOMED BASIC PACK I2Cleared 510(K)
- K903726DRAPE, SURGICAL - UTILITY DRAPE - STERILE2Cleared 510(K)
- K902384ABDOMINAL OR C-SECTION DRAPE SHEET2Cleared 510(K)
- K902031CUSTOMED LAP PACK IV2Cleared 510(K)
- K902030CUSTOMED LAP PACK III2Cleared 510(K)
- K902029CUSTOMED LAP PACK I2Cleared 510(K)
- K901465ABSORBABLE GAUZE DRAPE2Cleared 510(K)
- K900945LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING2Cleared 510(K)
- K896215MERCY HIP/KNEE PACK2Cleared 510(K)
- K897120EQUIP COVERS, STERILE2Cleared 510(K)
- K896367STERILE SURGICAL DRAPES AND SHEETS2Cleared 510(K)
- K895404UNDER BUTTOCKS DRAPE2Cleared 510(K)
- K895011TRIDENT DRAPE SUPPORT2Cleared 510(K)
- K894764OR TOWEL PACKS2Cleared 510(K)
- K894436MASCOT O.R. TOWEL2Cleared 510(K)
- K894433BATES BLANKET2Cleared 510(K)
- K893212THERMALAP2Cleared 510(K)
- K884231SURGICAL 'LASER' DRAPE2Cleared 510(K)
- K885099MULTIPLE (STERILE SURGICAL TOWELS)2Cleared 510(K)
- K890101FEMORAL ANGIOGRAPHY DRAPE2Cleared 510(K)
- K890709O.R. TOWELS (STERILE)2Cleared 510(K)
- K882643AM TM SYRGICAL DRAPES2Cleared 510(K)
- K890471PMS ANGIO DRAPE2Cleared 510(K)
- K890006BAXTER STERILE TOWEL2Cleared 510(K)
- K884057ELAN-E DISPOSABLE DRAPE2Cleared 510(K)
- K884112CARETEX OR TOWEL2Cleared 510(K)
- K883424SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB2Cleared 510(K)
- K882000PRO-FECT O.R. TOWEL2Cleared 510(K)
- K882724MICROTEK PROBE DRAPE2Cleared 510(K)
- K882494ELAN-E DISPOSALBE DRAPE2Cleared 510(K)
- K881396OPERATING ROOM TOWELS -STERILE & NON-STERILE2Cleared 510(K)
- K881479OPERATION ROOM TOWEL2Cleared 510(K)
- K880513DISP. NON-MAGNETIC SURGICAL INSTRU. DRAPE2Cleared 510(K)
- K875153THIELER KIT2Cleared 510(K)
- K8740863M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX2Cleared 510(K)
- K873141LASER RESISTANT DRAPE2Cleared 510(K)
- K873313SURGICAL DRAPE2Cleared 510(K)
- K872757OPSITE SPECIALITY DRAPES2Cleared 510(K)
- K872395CK 1600 SERIES, TOWELS2Cleared 510(K)
- K871068DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER2Cleared 510(K)
- K864388MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY2Cleared 510(K)
- K870123SURGICAL DRAPES AND ACCESSORIES USING PCCE FILM2Cleared 510(K)
- K870124SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM2Cleared 510(K)
- K870122SURGICAL DRAPES AND ACCESSORIES USING HYTREL FILM2Cleared 510(K)
- K865094LINEN (HUCK) TOWEL2Cleared 510(K)
- K864899SURGICAL DRAPE PACK2Cleared 510(K)
- K864697CK 6000 SERIES, TOWELS2Cleared 510(K)
- K864111STERILE FIELD #605 FENESTRATED STERILE FIELD #6062Cleared 510(K)
- K863323SENGEWALD CATALOG NUMBER 55 66 012Cleared 510(K)
- K863871OPERATING ROOM TOWELS - STERILE/NON STERILE2Cleared 510(K)
- K863732SURGICAL DRAPE & DRAPE ACCESSORIES2Cleared 510(K)
- K863512DRAPE STERICOVER2Cleared 510(K)
- K862801SPUNGUARD PLUS SURGICAL DRAPE2Cleared 510(K)
- K862577LINEN (HUCK) TOWEL2Cleared 510(K)
- K862438SURGICAL DRAPES AND DRAPE ACCESSORIES2Cleared 510(K)
- K862172QUALI-MED'S OPERATING ROOM DRAPES2Cleared 510(K)
- K862062NONWOVEN SURGICAL DRAPE PACK2Cleared 510(K)
- K862016PACH-PEN SURGICAL DRAPE2Cleared 510(K)
- K861969STERILE TOWEL W/ANTIMICROBIAL AGENT2Cleared 510(K)
- K861531DISPOSABLE SURGICAL DRAPES AND ACCESSORIES2Cleared 510(K)
- K861288NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES2Cleared 510(K)
- K861196STERILE STOCKINETTE W/ANTIMICROBIAL AGENT2Cleared 510(K)
- K860936ABSORBENT, FIBER, OPERATING ROOM TOWELS2Cleared 510(K)
- K850960NON-ABSORBENT DRAPES & ABSORBENT TOWELS2Cleared 510(K)
- K860326TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT2Cleared 510(K)
- K860447STANGUARD O.R. TOWEL PACK-4TOWEL PACK #2782204002Cleared 510(K)
- K860248100% COTTON ABSORBENT TOWEL2Cleared 510(K)
- K853347MAI STERILE UTILITY DRAPE2Cleared 510(K)
- K852945HUCK TOWEL2Cleared 510(K)
- K852280DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY)2Cleared 510(K)
- K850912STERILE DISPOSABLE PN DRAPE SYSTEM2Cleared 510(K)
- K851314ABCO DRAPES/TOWELS2Cleared 510(K)
- K850326STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH2Cleared 510(K)
- K850199POLY-LINED TOWEL/DRAPE LINE2Cleared 510(K)
- K844802SURGICAL DRAPES2Cleared 510(K)
- K843724I.V. START KIT & OBSTETRICAL KIT2Cleared 510(K)
- K844465PMS DRAPE PACK2Cleared 510(K)
- K844199ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET2Cleared 510(K)
- K843496DRAPE SURGICAL UTILITY DRAPE STERILE2Cleared 510(K)
- K843260ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE2Cleared 510(K)
- K841735ACU-DERM TRANSPARENT INCISE DRAPE2Cleared 510(K)
- K842545ALL-HANDS STERILE FIELD-02012Cleared 510(K)
- K842115SPUNGARD & SURG. DRAPES-GOWNS & PACKS2Cleared 510(K)
- K840957ANTIMICROBIAL INCISE DRAPE2Cleared 510(K)
- K833176SDI SURGICAL DRAPE2Cleared 510(K)
- K833877SINGLE-USE SURGICAL DRAPES2Cleared 510(K)
- K833122BURLINGTON ANTIMICROBIAL STOCKINEETTE2Cleared 510(K)
- K833121BURLINGTON STERILE ANTIMICROBIAL STOCK2Cleared 510(K)
- K831287E-Z FIT2Cleared 510(K)
- K832278LIGHT HANDLE COVER2Cleared 510(K)
- K832874ISOVIS WOUND PROTECTOR2Cleared 510(K)
- K830270ISOVIS WOUND PROTECTOR2Cleared 510(K)
- K830723REDI-DRAPE2Cleared 510(K)
- K830660STERILE SURGICAL DRAPES2Cleared 510(K)
- K823054DRAPE, SURGICAL ANGIOGRAPHY2Cleared 510(K)
- K822641GORE-TEX BARRIER SURG. DRAPES & GOWNS2Cleared 510(K)
- K822847INSTA-HOLD2Cleared 510(K)
- K820543BARRIER ANTIMICROBIAL INCISE DRAPE2Cleared 510(K)
- K820542SURGIKOS INCISE DRAPE2Cleared 510(K)
- K820850CURITY PREMIUM CYSTOSCOPY TRAY2Cleared 510(K)
- K820758BOUNDARY SINGLE-USE CRANIOTOMY SHEET2Cleared 510(K)
- K813360DERMAFILE (CAT. # 382Cleared 510(K)
- K813097ANAGO STERILE PRODUCTS; STOCKINETTES2Cleared 510(K)
- K820078DRAPE, SURGICAL2Cleared 510(K)
- K813450BOUNDARY SINGLE-USE DRAPES2Cleared 510(K)
- K813551SHEETS2Cleared 510(K)
- K813277BOUNDARY DRAPE TAPE2Cleared 510(K)
- K812962BOUNDARY SURGICAL DRAPE2Cleared 510(K)
- K812738BOUNDARY PROCESS CHANGE2Cleared 510(K)
- K812809STERILE ADHERENT DRAPES2Cleared 510(K)
- K812448UNI-THANE2Cleared 510(K)
- K8015503M GERMICIDAL SURGICAL INCISE DRAPE2Cleared 510(K)
- K811871BACTERICIDAL INCISE DRAPE2Cleared 510(K)
- K811996GATOR DRAPES2Cleared 510(K)
- K802790SOLVALINE2Cleared 510(K)
- K802980DISPOSABLE STERILE LAP SPONGE2Cleared 510(K)
- K802787METALLINE DRESSINGS2Cleared 510(K)
- K802797O.R. DRAPES2Cleared 510(K)
- K802652BOUNDARY SURGICAL DRAPES WITH ADHESIVE2Cleared 510(K)
- K802537DISPOSABLE SURGICAL DRAPE2Cleared 510(K)
- K802359DISP. FENESTRATED SURG. DRAPE SHEETS2Cleared 510(K)
- K802317COMFORT CUSHION DRY BURN PADS, STERILE2Cleared 510(K)
- K802280WHITE KNIGHT DRAPE SEAL2Cleared 510(K)
- K802213WHITE KNIGHT BOVIE CORD/SUCTION TUBE2Cleared 510(K)
- K802247BOUNDARY SINGLE-USE DRAPES2Cleared 510(K)
- K802192BOUNDARY SINGLE-USE DRAPES2Cleared 510(K)
- K802148BOUNDARY SINGLE-USE DRAPE2Cleared 510(K)
- K802050TACKMER INCISE DRAPE2Cleared 510(K)
- K802001LAP SPONGES CAT.#801-8502Cleared 510(K)
- K801864BARRIER APERTURED DRAPE2Cleared 510(K)
- K801863BARRIER TOWEL DRAPE2Cleared 510(K)
- K801132BOUNDARY EXTREMITY DRAPE2Cleared 510(K)
- K801068STERILE ABDOMINAL PAD2Cleared 510(K)
- K801033STERILE DRAPE 17X18 W/3 FENESTRATION2Cleared 510(K)
- K801032STERILE DRAPE 17X18 CODE D-6A2Cleared 510(K)
- K800928WHITE KNIGHT SUPPLEMENTAL DRAPE2Cleared 510(K)
- K800817SHIELD DISP. REINFORCED DRAPE SHEETS2Cleared 510(K)
- K800278MEDSPEC SAFETY PINS2Cleared 510(K)
- K800552ZEISS DISPOSABLE, STERILE SURGICAL DRAPE2Cleared 510(K)
- K800490STERILE DRESSING PACK2Cleared 510(K)
- K792621STERILIZATION PROCESS CHANGE BOUNDARY2Cleared 510(K)
- K792623STERILIZATION PROCESS/ABSORBENT TOWEL2Cleared 510(K)
- K792357STERILE IMPERVIOUS ORTHOPEDIC STOCKIN2Cleared 510(K)
- K792176DRAPE, MICROSCOPE2Cleared 510(K)
- K791864INSTRUMENT PAD2Cleared 510(K)
- K791719BARRIER & FACE MASK WITH INNER FACING2Cleared 510(K)
- K791486FABRIC 450* TOWEL DRAPE2Cleared 510(K)
- K791500BARRIER *450* TAPE STRIP2Cleared 510(K)
- K791439BARRIER* OVERHEAD TABLE DRAPE2Cleared 510(K)
- K791440BARRIER* X-RAY CASSETTE DRAPE2Cleared 510(K)
- K791438BARRIER* C-ARM DRAPE2Cleared 510(K)
- K780627SURG-O-PAK, GOWNS, SHEETS, AND TOWELS2Cleared 510(K)
- K790970SURGICAL FACE MASK2Cleared 510(K)
- K791070ACCU-SORB STERILE STOCKINETTES2Cleared 510(K)
- K791032CARDIAC CATHETERIZATION SHEETS/PACKS2Cleared 510(K)
- K790972KIMLON IMPERVIOUS STOCKINETTES2Cleared 510(K)
- K790725BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE*2Cleared 510(K)
- K790636KIMLON UNIVERSAL DRAPE2Cleared 510(K)
- K790431TREATED BARRIER INCISE DRAPE2Cleared 510(K)
- K790634IMPERVIOUS STERILE STOCKINETTE2Cleared 510(K)
- K790341DELTA-NET2Cleared 510(K)
- K782051DRAPES, DISPOSABLE SURGICAL2Cleared 510(K)
- K790234DRAPE PACKS, SURGICAL GOWNS2Cleared 510(K)
- K790225LIMB SHEET WITH FABRIC 4502Cleared 510(K)
- K790224PADIATRY PACK & SHEET WITH FABRIC 4502Cleared 510(K)
- K790053KELLEY-PLUS WITH MEASURETTE2Cleared 510(K)
- K782091STOCKINETTE, DISPOSABLESURGICAL2Cleared 510(K)
- K781959SURGICAL GOWNS, SHEETS2Cleared 510(K)
- K781944STOCKINETTE2Cleared 510(K)
- K781534SURG-O-PAK PREP PAD2Cleared 510(K)
- K781172U-DRAPE, BOUNDARY2Cleared 510(K)
- K780865MAGNETIC DRAPE - INSTRUMENT HOLDER2Cleared 510(K)
- K780548DISPOSA-LOOPS2Cleared 510(K)
- K781047DRAPE, SURGICAL-SPARTAN LIMB SHEET2Cleared 510(K)
- K781046IMPERVIOUS STOCKINET2Cleared 510(K)
- K780856BARRIER GYNECOLOGY PACK FABRIC 4502Cleared 510(K)
- K780841BARRIER MEDIUM SHEET 4502Cleared 510(K)
- K780840BARRIER LAPAROTOMY SHEET 4502Cleared 510(K)
- K780839BARRIER PEDIATRIC/INCISE DRAPE 4502Cleared 510(K)
- K780842BARRIER BASIC PACK FABRIC 4502Cleared 510(K)
- K780853OP-SITE ADHESIVE DRAPES2Cleared 510(K)
- K780844BARRIER OBSTETRICAL PACK FABRIC 4502Cleared 510(K)
- K780843BARRIER ABDOMINAL PACK FABRIC 4502Cleared 510(K)
- K780784ASPIRATION NEEDLE2Cleared 510(K)
- K780846DRAPING MATERIAL, COLBALT 60 STERILE2Cleared 510(K)
- K772387LEAD HAND2Cleared 510(K)
- K780036TOWEL, DRAPE, BOUNDARY2Cleared 510(K)
- K771136SURGICAL HEAD DRAPE, DISP.2Cleared 510(K)
- K771050HYPERALIMENTATION TRAY2Cleared 510(K)
- K771036SHAVE PREP TRAY2Cleared 510(K)
- K770799TRAY, IRRIGATION, STERILE, BASIC2Cleared 510(K)
- K770796SKIN SCRUB PREP SET2Cleared 510(K)
- K770621STOCKINETTE, SURGICAL2Cleared 510(K)
- K770560BARRIER O.B. PACK IV2Cleared 510(K)
- K770396DRAPES, MODESTY2Cleared 510(K)
- K760997UNDER BOTTOCKS DRAPE2Cleared 510(K)
- K770175SEA-BOND ADHEVISE DENTURE CUSHIONS2Cleared 510(K)
- K761204BARRIER IMPERVIOUS BACK TABLE COVER2Cleared 510(K)
- K760937BARRIER NEURO SHEET2Cleared 510(K)
- K760933BARRIER UNIVERSAL SHEET2Cleared 510(K)
- K760932BOUNDARY FABRIC III SURGICAL DRAPE2Cleared 510(K)
- K760890BARRIER IMPERVIOUS S-OCKINETTE2Cleared 510(K)
- K760867STERILE STOCKINETTE2Cleared 510(K)
- K760807BARRIER GENERAL SURGERY PACK2Cleared 510(K)
- K760212DRAPES, BARRIER, STERILE PATIENT READY2Cleared 510(K)
- LGXTable, Examination, Medical, Powered1Product Code
- LYUAccessory, Surgical Apparel1Product Code
- MACDecontamination Kit1Product Code
- MMPCover, Barrier, Protective2Product Code
- MSHRespirator, Surgical2Product Code
- NZPSealant, Microbial2Product Code
- OEANon-Surgical Isolation Gown1Product Code
- OKFBody Fluid Disposal Kit2Product Code
- OKGBody Fluid Clean Up Kit2Product Code
- OKHBody Fluids Barrier Kit2Product Code
- OKIEmergency Response Safety Kit2Product Code
- ONTN95 Respirator With Antimicrobial/Antiviral Agent2Product Code
- OPAPowder-Free Non-Natural Rubber Latex Surgeon'S Gloves1Product Code
- OUKSurgical Mask With Antimicrobial/Antiviral Agent2Product Code
- OVRKit, First Aid, Talking1Product Code
- OXZPediatric/Child Facemask2Product Code
- PIRMercy Tape 2d And 3d Models1Product Code
- PLYAntimicrobial Drapes2Product Code
- PQMSurgical Smoke Precipitator2Product Code
- QBWSurgical Apparel With Material Claims2Product Code
- QMXLabel Or Tag, Non-Sterile1Product Code
- QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection2Product Code
- QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs2Product Code
- 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
- 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
SENGEWALD CATALOG NUMBER 55 66 01
- Page Type
- Cleared 510(K)
- 510(k) Number
- K863323
- 510(k) Type
- Traditional
- Applicant
- SENGEWALD/USA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/29/1986
- Days to Decision
- 63 days