510(k) K140330
- Device
- 3M STERI-DRAPE FABRIC SURGICAL DRAPES
- Applicant
- 3M HEALTH CARE
- 510(k) number
- K140330
- Product code
- KKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-08-18
- Date received
- 2014-02-10
- 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
- MARK BURVILLE
- Address
- Bldg.275-5w-06 St. Paul MN US 55144 55144
FDA Registration Numbers#
- 3013557562
- 3006425876
- 1032347
- 3015625160
- 3010305275
- 3004122598
- 3009443860
- 1319639
- 3016607092
- 3013497020
- 3015276780
- 2032112
- 3006847952
- 3007082891
- 3015709932
- 1211998
- 3005997949
- 3012966700
- 3017820152
- 3027977504
- 1037885
- 1054241
- 3026606306
- 2427500
- 3013006775
- 3013283620
- 3011390076
- 1721686
- 3030954512
- 3013298431
- 8022129
- 9613558
- 3013820501
- 3008489813
- 1055892
- 3009600453
- 3008502431
- 9680794
- 3016761372
- 3015224777
- 1030451
- 9611024
- 1836161
- 3034669683
- 1644312
- 3011554160
- 3045817901
- 1065597
- 9610612
- 2022435
- 8043817
- 3011497662
- 9616088
- 3001124136
- 1417592
- 2246552
- 3013077751
- 2320762
- 3016844398
- 3017937325
- 3011140825
- 8030607
- 3028006458
- 3004967902
- 3006437555
- 1018470
- 3015612252
- 1423395
- 3004133236
- 3007007790
- 3007487007
- 3007886583
- 9611594
- 3044026004
- 3010684280
- 3005246893
- 3007829657
- 3013443304
- 3008352384
- 1527607
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 |
| 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 |
| K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | Exact Medical Manufacturing, Inc. | 2013-02-14 |
Legacy Summary#
summary
FDA Review#
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