510(k) K850960
- Device
- NON-ABSORBENT DRAPES & ABSORBENT TOWELS
- Applicant
- EXCEL HEALTH CARE PRODUCTS
- 510(k) number
- K850960
- Product code
- KKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-03-15
- Date received
- 1985-03-08
- Regulation
- 878.4370
- Classification name
- Drape, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL SHANNON
- Address
- 5001 Hadley Rd. S. Plainfield NJ US 07080 07080
FDA Registration Numbers#
- 3008309062
- 1644312
- 3003542872
- 3013443304
- 3009600453
- 3004911384
- 3006437555
- 3023228837
- 3005012805
- 9680934
- 3013868968
- 1651395
- 1055892
- 1319639
- 3009185973
- 3009719225
- 3018094310
- 3042940623
- 1054241
- 2320762
- 3013421458
- 3010487482
- 3015859709
- 1060680
- 3013283620
- 1211998
- 3017619652
- 3003495693
- 3006425876
- 1000563940
- 8043817
- 3014325891
- 3013429557
- 3011063460
- 3015173212
- 3006787036
- 3004967902
- 3013006775
- 3015276780
- 3007487007
- 3001003398
- 3044026004
- 3031841433
- 3006897899
- 3005246893
- 3014663814
- 9616088
- 3011500469
- 3011547453
- 8022129
- 3009443860
- 3005748481
- 3015625160
- 3015224777
- 3010684280
- 2939520
- 3012143814
- 3004361903
- 3013600605
- 3030626857
- 3035642068
- 1034084
- 1721676
- 3006847952
- 3028006458
- 1123010
- 3011390076
- 1424263
- 3045816907
- 1423395
- 1065597
- 3016844398
- 3011106828
- 3015895145
- 1422634
- 3013820501
- 9610612
- 3007886583
- 1055236
- 3012966700
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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