510(k) K172010
- Device
- Gel-e Bandage
- Applicant
- Gel-e, Inc. (formerly Remedium Technologies, Inc.)
- 510(k) number
- K172010
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-12-07
- Date received
- 2017-07-03
- 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
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Matthew Dowling
- Address
- 387 Technology Dr., Suite 3110b College Park MD US 20742 20742
FDA Registration Numbers#
- 1929833
- 8043396
- 3027448274
- 2029275
- 2024024
- 3017297225
- 2245539
- 3009882464
- 3012535730
- 3010668881
- 3015980493
- 3003636207
- 3009317711
- 3016615875
- 3031238659
- 3004146122
- 3007321028
- 3015309358
- 3015238043
- 3031743608
- 1646434
- 3019356409
- 3010600625
- 3003300673
- 3007663067
- 3017399129
- 3005920706
- 3004431266
- 3015542130
- 1221816
- 3030067857
- 1047843
- 3002907620
- 2530957
- 9680579
- 3008770963
- 2530154
- 3010894343
- 1225991
- 2245304
- 1835959
- 3005433617
- 3015442987
- 3025316685
- 1720734
- 1064858
- 3017633586
- 1648579
- 3008374791
- 8043792
- 3014498807
- 3014982332
- 3004170064
- 3007594734
- 3032911850
- 1220477
- 1121308
- 1650372
- 3031600472
- 3012823434
- 3036710971
- 3013012623
- 3017660750
- 3004799623
- 3027419979
- 3004117927
- 1649518
- 2245437
- 3012973796
- 3004189237
- 3006802076
- 2431866
- 3011276344
- 3039592366
- 3014820861
- 3013820501
- 9680091
- 3027517726
- 3009109670
- 3010187826
Source Documents#
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250115 | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025-10-14 |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | 2025-10-10 |
| K243166 | Dermalage | Infection Elimination Solutions, LLC | 2025-08-27 |
Legacy Summary#
summary
FDA Review#
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