510(k) K122634
- Device
- IODOFOAM IODOPHOR FOAM DRESSING
- Applicant
- PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC
- 510(k) number
- K122634
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-03-12
- Date received
- 2012-08-29
- 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
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MASON DIAMOND
- Address
- 150 Levinberg Ln. Wayne NJ US 07470 07470
FDA Registration Numbers#
- 2320762
- 1419520
- 1831301
- 3011862887
- 3009610508
- 9616088
- 3030067857
- 3009167225
- 9616874
- 3010288357
- 3009461428
- 3007841320
- 3008396914
- 1649518
- 3023113877
- 3007125968
- 2032098
- 3030229896
- 3003622638
- 9610694
- 3004637474
- 3009317711
- 3024856793
- 3033536319
- 3007007790
- 3016705853
- 3004727227
- 9610825
- 3007582648
- 3015821396
- 3033530347
- 3030625176
- 3013557562
- 3014461810
- 1649690
- 3034456223
- 3003755939
- 3006234743
- 2083373
- 3018507299
- 1123137
- 3019944216
- 3042953785
- 3012502601
- 3004713654
- 1836161
- 2183744
- 1720734
- 3007544634
- 3005920706
- 3004799623
- 3017396949
- 9614157
- 2022435
- 3010770024
- 3010132111
- 3010178296
- 3015547002
- 1066368
- 3029971427
- 3006498370
- 3007048057
- 3018167761
- 3010131578
- 1417411
- 1221816
- 3038356900
- 3005488444
- 3038624837
- 3012494290
- 3012448339
- 3013582868
- 1047843
- 3009486864
- 3010155648
- 2029412
- 3003185698
- 3002807314
- 3008132238
Source Documents#
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#
summary
FDA Review#
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