510(k) K000442
- Device
- ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
- Applicant
- MEDICAL CONCEPTS DEVELOPMENT, INC.
- 510(k) number
- K000442
- Product code
- KKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-04-24
- Date received
- 2000-02-10
- Regulation
- 878.4370
- Classification name
- Drape, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID PADGET
- Address
- 2500 Ventura Dr. Woodbury MN US 55125 55125
FDA Registration Numbers#
- 3011140825
- 3016096096
- 1211998
- 1065597
- 3007829657
- 1066741
- 1043549
- 3013429557
- 1034084
- 3010041511
- 3031757047
- 3030626857
- 3030446844
- 2427500
- 3012026312
- 3015173212
- 3015224777
- 3021274073
- 3001003398
- 3010305275
- 9613558
- 3006973666
- 8030607
- 3004713352
- 3011547453
- 3014579161
- 1032347
- 3015276780
- 3012495575
- 2939520
- 2022435
- 3013421458
- 3034669683
- 3007487007
- 3017820152
- 3013077751
- 3010885402
- 3010487482
- 3013557562
- 1625425
- 1643817
- 1123010
- 3011137372
- 3043226252
- 1527185
- 3045816907
- 3004122598
- 3008489813
- 3006437555
- 9680794
- 1644312
- 1054241
- 3012966700
- 1030451
- 3011390076
- 3045817901
- 3015531959
- 3044026004
- 1219930
- 3013410562
- 3005369776
- 8043817
- 1527607
- 3008502431
- 3013868968
- 3001124136
- 3041276890
- 3013665681
- 3019924
- 3003495693
- 3015625160
- 3006540014
- 1055236
- 2648727
- 3007082891
- 3011497662
- 1424263
- 3010684280
- 3013466775
- 3015895145
Source Documents#
Other 510(k) Records For Product Code KKX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230645 | BeneHold™ Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. | 2023-10-25 |
| K222578 | 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 3M Company | 2023-05-18 |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobial | Avery Dennison Belgie Bvba | 2021-07-30 |
| K200238 | ControlRad Sterile Cover | Controlrad, Inc. | 2020-04-26 |
| K163556 | MediClear PreOp | Covalontechnologies, Inc. | 2017-09-14 |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | Foshan Nanhai Plus Medical Co, Ltd. | 2015-06-24 |
| K141324 | HONGYU DISPOSABLE SURGICAL DRAPES | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2015-04-14 |
| K140195 | SURGICAL DRAPE | Griffith-Lucas, LLC | 2014-09-10 |
| K140330 | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | 3M Healthcare | 2014-08-18 |
| K141438 | WHITNEY MEDICAL SOLUTIONS ESHIELD | Whitney Medical Solutions | 2014-08-14 |
| K140250 | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE | 3M Healthcare | 2014-07-25 |
| K140064 | SURGISLEEVE WOUND PROTECTOR | Covidien | 2014-03-12 |
| K131571 | AVD RIGHT RADIAL DRAPE | Advanced Vascular Dynamics | 2014-01-31 |
| K130404 | TIBURON SURGICAL DRAPE | Cardinal Health200, LLC | 2013-07-05 |
| K121436 | DAS MEDICAL EQUIPMENT DRAPES | Das Medical, LLC | 2013-06-06 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases