Panels › General, Plastic Surgery › Product code KKX · Class 2
Drape, Surgical, Antimicrobial
Regulation 878.4370
0510(k)s in 12 months (450 all time)
3recalls in 12 months (92 all time)
57recalls that name a 510(k)
Top companies in KKX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 25, 2023 | K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial II Avery Dennison Medical , Ltd., IE | KKX |
| May 18, 2023 | K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) 3M Company | KKX |
| Jul 30, 2021 | K202208 | BeneHold Surgical Incise Drape with CHG antimicrobial Avery Dennison Belgie Bvba, BE | KKX |
| Apr 26, 2020 | K200238 | ControlRad Sterile Cover Controlrad, Inc. | KKX |
| Sep 14, 2017 | K163556 | MediClear PreOp Covalontechnologies, Inc., CA | KKX |
| Jun 24, 2015 | K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX Foshan Nanhai Plus Medical Co, Ltd. | KKX |
| Apr 14, 2015 | K141324 | HONGYU DISPOSABLE SURGICAL DRAPES Weihai Hongyu Nonwoven Fabric Products Co., Ltd., CN | KKX |
| Sep 10, 2014 | K140195 | SURGICAL DRAPE Griffith-Lucas, LLC, CN | KKX |
| Aug 18, 2014 | K140330 | 3M STERI-DRAPE FABRIC SURGICAL DRAPES 3M Healthcare | KKX |
| Aug 14, 2014 | K141438 | WHITNEY MEDICAL SOLUTIONS ESHIELD Whitney Medical Solutions | KKX |
| Jul 25, 2014 | K140250 | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE 3M Healthcare | KKX |
| Mar 12, 2014 | K140064 | SURGISLEEVE WOUND PROTECTOR Covidien | KKX |
| Jan 31, 2014 | K131571 | AVD RIGHT RADIAL DRAPE Advanced Vascular Dynamics | KKX |
| Jul 5, 2013 | K130404 | TIBURON SURGICAL DRAPE Cardinal Health200, LLC | KKX |
| Jun 6, 2013 | K121436 | DAS MEDICAL EQUIPMENT DRAPES Das Medical, LLC | KKX |
| Feb 14, 2013 | K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV Exact Medical Manufacturing, Inc. | KKX |
| Dec 12, 2012 | K122000 | HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER Changzhou Holymed Products Co., Ltd., CN | KKX |
| May 8, 2012 | K112378 | COBES SURGICAL DRAPE Cobes Industries Co., Ltd. | KKX |
| Dec 1, 2011 | K111458 | GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS Gri Medical & Electronic Technology Co., Ltd. | KKX |
| Sep 29, 2011 | K112136 | TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE Kunshan Jiehong Nonwoven Product Co., Ltd. | KKX |
| Jan 13, 2011 | K102861 | SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) A Plus International, Inc. | KKX |
| Jan 4, 2011 | K101350 | RADSCAN EQUIPMENT SLICKER Radscan Medical Equipment, Inc. | KKX |
| Nov 19, 2010 | 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. | KKX |
| Nov 9, 2010 | K102666 | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM Kimberly-Clark Corp. | KKX |
| Oct 5, 2010 | K100991 | IMC SURGICAL DRAPE International Medsurg Connection | KKX |
| Oct 4, 2010 | K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) Exact Medical Manufacturing, Inc. | KKX |
| Sep 20, 2010 | K101689 | EMM EQUIPMENT COVER-POLYTHYLENE Exact Medical Manufacturing, Inc. | KKX |
| Sep 20, 2010 | K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 Exact Medical Manufacturing, Inc. | KKX |
| May 6, 2010 | K093909 | BUSSE SURGICAL DRAPES IV Busse Hospital Disposables, Inc. | KKX |
| Apr 20, 2010 | K100208 | IMC SURGICAL DRAPE International Medsurg Connection | KKX |
| Oct 9, 2009 | K092212 | BUSSE SURGICAL DRAPES III Busse Hospital Disposables, Inc. | KKX |
| Sep 22, 2009 | K091343 | MRI NEURO DRAPE Surgivision, Inc. | KKX |
| Mar 25, 2009 | K083234 | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 Kimberly-Clark Corp. | KKX |
| Mar 6, 2009 | K083320 | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE Dukal Corp. | KKX |
| Feb 26, 2009 | K083424 | BUSSE SURGICAL DRAPE Busse Hosipital Disposables | KKX |
| Dec 9, 2008 | K082297 | BUSSE SURGICAL DRAPE Busse Hospital Disposables, Inc. | KKX |
| Nov 17, 2008 | K080796 | SRI LP DRAPE Sri/Surgical Express | KKX |
| Oct 20, 2008 | K080629 | PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS Promedical Products Co., Ltd., CN | KKX |
| Aug 8, 2008 | K081476 | SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE Surgical Concept Designs | KKX |
| Jul 21, 2008 | K080341 | ENDODRAPE(TM) Vortek Surgical, LLC | KKX |
| Oct 10, 2007 | K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES Arrow Intl., Inc. | KKX |
| Sep 24, 2007 | K070432 | GENERAL SURGERY DRAPES Welmed, Inc. | KKX |
| Jul 30, 2007 | K070406 | ENDODRAPE Vortek Surgical, LLC | KKX |
| Mar 5, 2007 | K062480 | JOYKEY SURGICAL DRAPES (STERILE) Joykey Industryial , Ltd. | KKX |
| Sep 25, 2006 | K061422 | SURGICAL DRAPES Austin Medical, Inc. | KKX |
| Aug 1, 2006 | K061762 | TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N Cardinal Health, Inc. | KKX |
| Jul 24, 2006 | K052668 | OR SPECIFIC BIG CASE BACK TABLE COVER Or Specific, Inc. | KKX |
| May 31, 2006 | K060200 | MICROTEK MEDICAL WARMING DRAPE Microtek Medical, Inc. | KKX |
| Mar 16, 2006 | K053495 | EQUIPMENT SLUSH DRAPE Advance Medical Designs, Inc. | KKX |
| Feb 15, 2006 | K052833 | GORE-TEX NON-STERILE SURGICAL GOWNS Medline Industries, Inc. | KKX |
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