510(k) K953654
- Device
- ORS-111
- Applicant
- O.R. SOLUTIONS, INC.
- 510(k) number
- K953654
- Product code
- KKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-09-22
- Date received
- 1995-08-02
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK LICATA
- Address
- 14014 Sullyfield Cir. Suite A Chantilly VA US 22021 22021
FDA Registration Numbers#
- 3006787036
- 3006437555
- 9610612
- 3041276890
- 3030446844
- 3000268902
- 9616088
- 3006538822
- 3007143236
- 3013298431
- 3018094310
- 1527185
- 3004122598
- 3028006458
- 3008502431
- 3016555232
- 9611024
- 3005997949
- 3018781093
- 3014421917
- 3015612252
- 2029015
- 2032841
- 3030626857
- 3009185973
- 3012026312
- 3005748481
- 3026606306
- 3004361903
- 1061124
- 1055236
- 3006425876
- 3009600453
- 3011063460
- 3008352384
- 3016761372
- 3013497020
- 3013421458
- 3005675811
- 3004111573
- 3043226252
- 3013820501
- 3011137372
- 1313525
- 3013466775
- 3044026004
- 8022129
- 1066741
- 3017820152
- 1420054
- 2246552
- 3001124136
- 3015960676
- 9616876
- 3014635169
- 9680794
- 1625425
- 3013665681
- 3034669683
- 3021274073
- 3031841433
- 3007082891
- 2523676
- 1037577
- 1527607
- 3011237770
- 3013443304
- 3023228837
- 1054069
- 1065597
- 3010684280
- 3003542872
- 3008595179
- 1417592
- 1423625
- 3027977504
- 3009542933
- 3012421607
- 1018470
- 3016607092
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#
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
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