510(k) K912490
- Device
- CITATION MEDICAL SCOPE PROCEDURE PACK
- Applicant
- CITATION MEDICAL CORP.
- 510(k) number
- K912490
- Product code
- KKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-08-16
- Date received
- 1991-06-04
- 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
- EDWARD F WADDELL
- Address
- 230 Edison Way Reno NV US 89502 89502
FDA Registration Numbers#
- 2523676
- 1422634
- 9615551
- 3008824097
- 3007829657
- 3013820501
- 3006538822
- 3030954512
- 3034669683
- 1836161
- 3038356900
- 3011547453
- 2939520
- 3013006775
- 3028006458
- 2032112
- 1211998
- 1043646
- 3006437555
- 3015960676
- 2427500
- 1043549
- 1420054
- 1721686
- 1043644
- 1054069
- 3027977504
- 1527185
- 1123137
- 3013497020
- 3001124136
- 3014421917
- 9611594
- 3015531959
- 1048735
- 1721676
- 3011106828
- 3035642068
- 3013600605
- 3006897899
- 3016844398
- 3006847952
- 3006891803
- 3044026004
- 3007289408
- 3018094310
- 3011497662
- 3013298431
- 3015612252
- 3005246893
- 1037577
- 1032347
- 3016761372
- 1054241
- 1065597
- 1036836
- 1651395
- 3009888344
- 3010487482
- 3009443860
- 1047843
- 3003495693
- 3045817901
- 8020785
- 9680646
- 1423395
- 9616088
- 1018470
- 3008595179
- 3013188547
- 3007886583
- 3031757047
- 3011390076
- 3013466775
- 1644312
- 3043226252
- 3010305275
- 9680284
- 2246552
- 9616876
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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