510(k) K211972
- Device
- Omeza Collagen Matrix
- Applicant
- Omeza, LLC
- 510(k) number
- K211972
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-09-01
- Date received
- 2021-06-24
- 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
- Thomas Gardner
- Address
- 25 S. Osprey Ave. Sarasota FL US 34236 34236
FDA Registration Numbers#
- 1225598
- 3016807311
- 3008806809
- 3042366049
- 3005706359
- 3014461810
- 3016504086
- 3032911850
- 1929833
- 3006784948
- 3017517906
- 3003418325
- 3013764800
- 3004681519
- 1720929
- 3004799623
- 3007329020
- 3013188547
- 2135339
- 3009486864
- 9680357
- 2954718
- 3005113244
- 3038637162
- 1060680
- 3006498370
- 3010763707
- 3026399481
- 1648579
- 1221816
- 3014312726
- 3008132398
- 2530957
- 2431014
- 1819174
- 3019944216
- 3013035118
- 3008374791
- 3005920706
- 3007125968
- 3010610950
- 3015077448
- 3005761322
- 3042953785
- 3030067857
- 8010803
- 3005818605
- 3027977504
- 2031987
- 3007735241
- 3010824458
- 2024024
- 3009931872
- 3004554409
- 3007321028
- 3012973796
- 3010160527
- 1000317571
- 3022754162
- 3002907620
- 1043214
- 3007648359
- 3024856793
- 1018120
- 3033530347
- 1314417
- 3022133572
- 3005621808
- 3031168520
- 3005004019
- 3017509841
- 3005669815
- 1319660
- 3011862887
- 3006785496
- 3009348823
- 3012494290
- 3002787468
- 3010060216
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#
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