510(k) K891133
- Device
- VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS
- Applicant
- ELWYN, INC.
- 510(k) number
- K891133
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-24
- Date received
- 1989-03-03
- Regulation
- 510(k) Premarket Notification
- Classification name
- Dressing, Wound, Drug
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- A WASHINGTON
- Address
- Elwyn PA US 19063 19063
FDA Registration Numbers#
- 1034876
- 1422634
- 3009109670
- 3011210302
- 3008562678
- 1836161
- 1649690
- 3038356900
- 3023994877
- 3003775072
- 3009171251
- 1423662
- 3017297225
- 3005694677
- 3017107376
- 3009504230
- 3010419931
- 3016904853
- 3004125670
- 3007187674
- 3009701308
- 3025431504
- 3007966889
- 1054241
- 9681630
- 3019843904
- 1036836
- 3039435289
- 3006784948
- 1018470
- 3006606901
- 1417411
- 3016851379
- 3009167225
- 3011987967
- 3005004019
- 3029971427
- 9615014
- 3004170064
- 3011238790
- 2183744
- 3010363503
- 3014004349
- 3045857302
- 1480288
- 3016116741
- 3012421607
- 3014146451
- 3032911850
- 3002787468
- 3002636527
- 3004681519
- 3007321028
- 3030926959
- 3034456223
- 3015276780
- 3004496953
- 9615662
- 3016678045
- 3015200795
- 2124143
- 1423507
- 3019944216
- 3007648359
- 3012481754
- 9616874
- 3009750086
- 2280705
- 3015142802
- 3003418325
- 3005920706
- 2083373
- 1646434
- 3014461810
- 3030229896
- 3017509841
- 9680091
- 1055236
- 3016450032
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | 2026-06-24 |
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026-06-24 |
| K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | 2026-06-17 |
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | 2026-05-13 |
| K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026-04-07 |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | 2026-03-25 |
| K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | 2026-03-13 |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | 2026-01-23 |
| K250890 | SBC1 Cream | Sioxmed, LLC | 2026-01-12 |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026-01-08 |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2026-01-05 |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025-12-19 |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | Huizhou Foryou Medical Devices Co., Ltd. | 2025-11-19 |
Legacy Summary#
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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