510(k) K132329
- Device
- NIVATOPIC PLUS
- Applicant
- NIVAGEN PHARMACEUTICALS INC.
- 510(k) number
- K132329
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-12-20
- Date received
- 2013-07-26
- 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
- LARA NOAH
- Address
- 248 Latitude Ln. Suite 104 Lake Wiley SC US 29710 29710
FDA Registration Numbers#
- 3016851379
- 3007007790
- 1646434
- 3013557562
- 3012979524
- 8044178
- 3012111117
- 3019543072
- 1649690
- 3018348
- 3012026312
- 3016116741
- 3007536356
- 1423507
- 1423662
- 3012973796
- 1036836
- 3029875292
- 3042366049
- 9614157
- 1526711
- 3006506075
- 3015547002
- 1319660
- 3005694677
- 3009931872
- 3004713654
- 3006946276
- 3014258951
- 2031987
- 3013582868
- 3013298431
- 3006218807
- 3013521734
- 3009167225
- 1647149
- 3003524577
- 3016601021
- 9680357
- 2029412
- 3030926959
- 3039169663
- 1645368
- 1720734
- 3004496953
- 3026544741
- 3005706359
- 3008132238
- 3010178296
- 3010363503
- 3016450032
- 3006785496
- 9680091
- 3015058854
- 2135339
- 3007648359
- 1225598
- 3007128716
- 1000317571
- 3019944216
- 3044026004
- 3006052875
- 3009134884
- 3013671177
- 1836161
- 3009655869
- 3023548698
- 3009848807
- 3017509841
- 3003775072
- 3005920706
- 1719513
- 3012456427
- 9615014
- 3010034780
- 2320762
- 1025483
- 3030172764
- 3007120504
Source Documents#
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-08-14 |
| K253665 | Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC | 2026-08-11 |
| 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 |
Legacy Summary#
summary
FDA Review#
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