510(k) K050322
- Device
- MICROTEK EQUIPMENT DRAPES
- Applicant
- MICROTEK MEDICAL, INC.
- 510(k) number
- K050322
- Product code
- KKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-05-17
- Date received
- 2005-02-09
- 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
- THOMAS BONNER
- Address
- 512 Lehmberg Rd. Columbus MS US 39702 39702
FDA Registration Numbers#
- 1721676
- 3015859709
- 9680357
- 3013298431
- 3006847952
- 9611024
- 3030446844
- 3001003398
- 3014579161
- 2648727
- 1054069
- 3015895145
- 3016761372
- 3015612252
- 3041276890
- 3015224777
- 1920664
- 3006723155
- 3009888344
- 3007829657
- 3015153469
- 3006787036
- 3011106828
- 3004713654
- 3030626857
- 3016096096
- 3013283620
- 3005595283
- 3034669683
- 2031963
- 3011497662
- 3026606306
- 3012966700
- 3015173212
- 3013006775
- 9613558
- 1527185
- 3001650535
- 1066741
- 3001675293
- 3013077751
- 3005246893
- 2939520
- 3013421458
- 1032347
- 2029015
- 3023228837
- 3007289408
- 3013443304
- 1043644
- 8030607
- 3027977504
- 9616088
- 2182979
- 1055236
- 3011063460
- 1065597
- 1037885
- 8020785
- 3017619652
- 8022129
- 9680934
- 1030451
- 1034084
- 1047843
- 3009542933
- 3005012805
- 3014421917
- 1061124
- 3005748481
- 3018094310
- 3001124136
- 3004911384
- 1043214
- 3007886583
- 3042940623
- 3017820152
- 1018470
- 3011554160
- 3012421607
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#
summary
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