FDA Product Code
FDA Product Code KKX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4370
510(k) Clearances — 450 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. | 2023-10-25 | Traditional | PDF ↗ |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 3M Company | 2023-05-18 | Traditional | PDF ↗ |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobial | Avery Dennison Belgie Bvba | 2021-07-30 | Traditional | PDF ↗ |
| K200238 | ControlRad Sterile Cover | Controlrad, Inc. | 2020-04-26 | Traditional | PDF ↗ |
| K163556 | MediClear PreOp | Covalontechnologies, Inc. | 2017-09-14 | Traditional | PDF ↗ |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | Foshan Nanhai Plus Medical Co, Ltd. | 2015-06-24 | Traditional | PDF ↗ |
| K141324 | HONGYU DISPOSABLE SURGICAL DRAPES | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2015-04-14 | Traditional | PDF ↗ |
| K140195 | SURGICAL DRAPE | Griffith-Lucas, LLC | 2014-09-10 | Traditional | PDF ↗ |
| K140330 | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | 3M Healthcare | 2014-08-18 | Traditional | PDF ↗ |
| K141438 | WHITNEY MEDICAL SOLUTIONS ESHIELD | Whitney Medical Solutions | 2014-08-14 | Traditional | PDF ↗ |
| K140250 | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE | 3M Healthcare | 2014-07-25 | Traditional | PDF ↗ |
| K140064 | SURGISLEEVE WOUND PROTECTOR | Covidien | 2014-03-12 | Traditional | PDF ↗ |
| K131571 | AVD RIGHT RADIAL DRAPE | Advanced Vascular Dynamics | 2014-01-31 | Traditional | PDF ↗ |
| K130404 | TIBURON SURGICAL DRAPE | Cardinal Health200, LLC | 2013-07-05 | Traditional | PDF ↗ |
| K121436 | DAS MEDICAL EQUIPMENT DRAPES | Das Medical, LLC | 2013-06-06 | Traditional | PDF ↗ |
| K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | Exact Medical Manufacturing, Inc. | 2013-02-14 | Traditional | PDF ↗ |
| K122000 | HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER | Changzhou Holymed Products Co., Ltd. | 2012-12-12 | Traditional | PDF ↗ |
| K112378 | COBES SURGICAL DRAPE | Cobes Industries Co., Ltd. | 2012-05-08 | Traditional | PDF ↗ |
| K111458 | GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS | Gri Medical & Electronic Technology Co., Ltd. | 2011-12-01 | Traditional | PDF ↗ |
| K112136 | TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE | Kunshan Jiehong Nonwoven Product Co., Ltd. | 2011-09-29 | Traditional | PDF ↗ |
| K102861 | SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) | A Plus International, Inc. | 2011-01-13 | Traditional | PDF ↗ |
| K101350 | RADSCAN EQUIPMENT SLICKER | Radscan Medical Equipment, Inc. | 2011-01-04 | Traditional | PDF ↗ |
| K094016 | NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H | Hinson and Hale Medical Technologies, Inc. | 2010-11-19 | Traditional | PDF ↗ |
| K102666 | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM | Kimberly-Clark Corp. | 2010-11-09 | Abbreviated | PDF ↗ |
| K100991 | IMC SURGICAL DRAPE | International Medsurg Connection | 2010-10-05 | Traditional | PDF ↗ |
| K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) | Exact Medical Manufacturing, Inc. | 2010-10-04 | Traditional | PDF ↗ |
| K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | Exact Medical Manufacturing, Inc. | 2010-09-20 | Traditional | PDF ↗ |
| K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | Exact Medical Manufacturing, Inc. | 2010-09-20 | Traditional | PDF ↗ |
| K093909 | BUSSE SURGICAL DRAPES IV | Busse Hospital Disposables, Inc. | 2010-05-06 | Traditional | PDF ↗ |
| K100208 | IMC SURGICAL DRAPE | International Medsurg Connection | 2010-04-20 | Special | PDF ↗ |
| K092212 | BUSSE SURGICAL DRAPES III | Busse Hospital Disposables, Inc. | 2009-10-09 | Special | PDF ↗ |
| K091343 | MRI NEURO DRAPE | Surgivision, Inc. | 2009-09-22 | Traditional | PDF ↗ |
| K083234 | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 | Kimberly-Clark Corp. | 2009-03-25 | Traditional | PDF ↗ |
| K083320 | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE | Dukal Corp. | 2009-03-06 | Traditional | PDF ↗ |
| K083424 | BUSSE SURGICAL DRAPE | Busse Hosipital Disposables | 2009-02-26 | Traditional | PDF ↗ |
| K082297 | BUSSE SURGICAL DRAPE | Busse Hospital Disposables, Inc. | 2008-12-09 | Traditional | PDF ↗ |
| K080796 | SRI LP DRAPE | Sri/Surgical Express | 2008-11-17 | Abbreviated | PDF ↗ |
| K080629 | PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS | Promedical Products Co., Ltd. | 2008-10-20 | Traditional | PDF ↗ |
| K081476 | SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE | Surgical Concept Designs | 2008-08-08 | Traditional | PDF ↗ |
| K080341 | ENDODRAPE(TM) | Vortek Surgical, LLC | 2008-07-21 | Abbreviated | PDF ↗ |
| K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES | Arrow Intl., Inc. | 2007-10-10 | Traditional | PDF ↗ |
| K070432 | GENERAL SURGERY DRAPES | Welmed, Inc. | 2007-09-24 | Traditional | PDF ↗ |
| K070406 | ENDODRAPE | Vortek Surgical, LLC | 2007-07-30 | Traditional | PDF ↗ |
| K062480 | JOYKEY SURGICAL DRAPES (STERILE) | Joykey Industryial , Ltd. | 2007-03-05 | Traditional | PDF ↗ |
| K061422 | SURGICAL DRAPES | Austin Medical, Inc. | 2006-09-25 | Traditional | PDF ↗ |
| K061762 | TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N | Cardinal Health, Inc. | 2006-08-01 | Special | PDF ↗ |
| K052668 | OR SPECIFIC BIG CASE BACK TABLE COVER | Or Specific, Inc. | 2006-07-24 | Traditional | PDF ↗ |
| K060200 | MICROTEK MEDICAL WARMING DRAPE | Microtek Medical, Inc. | 2006-05-31 | Traditional | PDF ↗ |
| K053495 | EQUIPMENT SLUSH DRAPE | Advance Medical Designs, Inc. | 2006-03-16 | Traditional | PDF ↗ |
| K052833 | GORE-TEX NON-STERILE SURGICAL GOWNS | Medline Industries, Inc. | 2006-02-15 | Abbreviated | PDF ↗ |
| K052395 | STERILE EQUIPMENT COVERS | Volcano Corporation | 2005-12-01 | Traditional | PDF ↗ |
| K052169 | IMC SURGICAL DRAPES | International Medsurg Connection, Inc. | 2005-11-17 | Traditional | PDF ↗ |
| K043015 | 3L SURGICAL DRAPES | 3l Medical Products Co., Ltd. | 2005-08-15 | Traditional | PDF ↗ |
| K051625 | BARRIER SURGICAL DRAPES | Molnlycke Health Care, Inc. | 2005-07-14 | Special | PDF ↗ |
| K050538 | IMC DRAPES | Intl. Medsurg Connection, Inc. | 2005-06-07 | Traditional | PDF ↗ |
| K050322 | MICROTEK EQUIPMENT DRAPES | Microtek Medical, Inc. | 2005-05-17 | Traditional | PDF ↗ |
| K042977 | LASIK EYE DRAPE | Odyssey Medical, Inc. | 2005-05-10 | Traditional | PDF ↗ |
| K050508 | HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES | Haywood Vocational Opportunities | 2005-04-27 | Traditional | PDF ↗ |
| K042526 | DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX | Medical Action Industries, Inc. | 2005-04-25 | Traditional | PDF ↗ |
| K032666 | MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES | Medline Industries, Inc. | 2005-03-16 | Traditional | PDF ↗ |
| K042893 | UNDER BUTTOCKS DRAPE | International Medsurg Connection, Inc. | 2005-03-11 | Traditional | PDF ↗ |
| K041224 | FOOTHILLS SURGICAL DRAPES | Foothills Industries, Inc. | 2005-02-03 | Traditional | PDF ↗ |
| K042131 | PROMEDICAL SURGICAL DRAPES | Promedical Products Co., Ltd. | 2004-12-10 | Traditional | PDF ↗ |
| K042137 | PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS | Promedical Products Co., Ltd. | 2004-10-05 | Traditional | PDF ↗ |
| K041846 | SABRESOURCE DRAPE | Minrad, Inc. | 2004-08-26 | Traditional | PDF ↗ |
| K041077 | IMALUX OCT PROBE GUIDE | Imalux Corporation | 2004-06-25 | Traditional | PDF ↗ |
| K031889 | ALEXIS WOUND RETRACTOR | Applied Medical Resources Corp. | 2003-09-22 | Traditional | PDF ↗ |
| K031287 | STERI-DRAPE SURGICAL DRAPES | 3M Company | 2003-09-10 | Traditional | PDF ↗ |
| K030908 | DEROYAL SURGICAL DRAPES BACKTABLE COVER | Deroyal | 2003-08-11 | Traditional | PDF ↗ |
| K031131 | KLINIDRAPE SURGICAL DRAPES | Molnlycke Health Care | 2003-06-10 | Traditional | PDF ↗ |
| K031362 | LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS | Lac Mac, Ltd. | 2003-05-30 | Traditional | PDF ↗ |
| K030365 | DEROYAL DRAPES, STERILE, NON-STERILE | Deroyal Industries, Inc. | 2003-04-29 | Traditional | PDF ↗ |
| K023419 | TRILAMINATE DRAPES/TIBURON | Allegiance Healthcare Corp. | 2003-02-11 | Traditional | PDF ↗ |
| K022868 | PRIMAGARD SURGICAL EQUIPMENT DRAPES | Primeline Medical Products, Inc. | 2002-11-08 | Traditional | PDF ↗ |
| K023117 | PRIMAGARD SURGICAL GOWNS | Primeline Medical Products, Inc. | 2002-11-08 | Traditional | PDF ↗ |
| K023425 | DRAPES WITH ABSORBENT REINFORCEMENT | Allegiance Healthcare Corp. | 2002-11-06 | Special | PDF ↗ |
| K023432 | MEDLINE ASEP PLUS SURGICAL DRAPES | Medline Industries, Inc. | 2002-11-04 | Special | PDF ↗ |
| K021864 | PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142) | Primeline Medical Products, Inc. | 2002-09-23 | Traditional | PDF ↗ |
| K020581 | COLOSHIELD COLONOSCOPY DRAPE MODEL E2000 | Medical Concepts Development, Inc. | 2002-09-18 | Traditional | PDF ↗ |
| K013958 | INDUS TEXTILES TOWEL-STERILE AND NON-STERILE | Indus Textiles, Inc. | 2002-08-19 | Traditional | PDF ↗ |
| K020393 | MASTER & FRANK SURGICAL DRAPES (STERILE) | Master & Frank Enterprses Co., Ltd. | 2002-05-03 | Traditional | PDF ↗ |
| K020435 | WOUND PROTECTOR/RETRACTOR | Applied Medical Resources Corp. | 2002-04-15 | Traditional | PDF ↗ |
| K012957 | TOWEL DRAPE, MODELS 4409, 4410 | Dynarex Corp. | 2002-03-06 | Traditional | PDF ↗ |
| K012237 | MERTEX-PLUS REUSABLE SURGICAL DRAPE | Mercan AB | 2001-10-15 | Traditional | PDF ↗ |
| K012807 | MODIFICATION TO: COMPEL SURGICAL DRAPES | Standard Textile Co., Inc. | 2001-10-11 | Special | PDF ↗ |
| K012168 | ADVANCE MEDICAL DESIGNS FLUID POUCH | Advance Medical Designs, Inc. | 2001-09-18 | Traditional | PDF ↗ |
| K011422 | SURGICAL DRAPES | Advance Medical Designs, Inc. | 2001-07-10 | Traditional | PDF ↗ |
| K010711 | ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR | Advanced Surgical Concepts (Asc) | 2001-05-22 | Traditional | PDF ↗ |
| K000442 | ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX | Medical Concepts Development, Inc. | 2001-04-24 | Traditional | PDF ↗ |
| K010572 | BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE | Becton, Dickinson and Co. | 2001-03-12 | Special | PDF ↗ |
| K003670 | PATIENT DRAPE, SURGICAL | Advance Medical Designs, Inc. | 2001-01-26 | Traditional | PDF ↗ |
| K002691 | COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE | Com-Med International, Inc. | 2000-12-08 | Traditional | PDF ↗ |
| K002702 | NEUROTOLOGY DRAPE, MODEL TBD | Gyrus Ent LLC | 2000-10-26 | Traditional | PDF ↗ |
| K002508 | EQUIPMENT DRAPES | Allegiance Healthcare Corp. | 2000-09-01 | Special | PDF ↗ |
| K001858 | OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE | China Nantong Guangda Textile Co., Ltd. | 2000-08-17 | Traditional | PDF ↗ |
| K002419 | SURGICAL DRAPES | Allegiance Healthcare Coporation | 2000-08-15 | Special | PDF ↗ |
| K001994 | EEI SLUSH PAN DRAPE | Eagle Endoscopic, Inc. | 2000-08-04 | Traditional | PDF ↗ |
| K001667 | RESOLVE SURGICAL O.R. TOWELS | Allegiance Healthcare Corp. | 2000-06-23 | Traditional | PDF ↗ |
| K000906 | KLINIDRAPE SURGICAL DRAPES | Molnlycke Health Care, Inc. | 2000-06-23 | Traditional | PDF ↗ |
| K994199 | VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR | Custom Medical Products, Inc. | 2000-06-09 | Traditional | PDF ↗ |
Product code KKX · Class II · General, Plastic Surgery. Data: openFDA.