510(k) K161311
- Device
- USP Sterile Water, 120 ML Cup, USP Sterile Normal Saline (0.9% Sodium Chloride), 120 ML Cup, USP Sterile Water, 100 ML,250 ML And 500 ML Bottles, USP Sterile Normal Saline (0.9% Sodium Chloride), 100 ML, 250 ML And 500 ML Bottles
- Applicant
- STRUKMYER MEDICAL LLC
- 510(k) number
- K161311
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-08-29
- Date received
- 2016-05-10
- 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
- ROBERT DELK
- Address
- 1801 Big Town Suite 100 Mesquite TX US 75149 75149
FDA Registration Numbers#
- 3007536356
- 3011089435
- 3009973323
- 9610825
- 3007128716
- 3012907824
- 8043484
- 3010610950
- 3010315629
- 3013582868
- 3018507299
- 3003524577
- 1480288
- 3010419931
- 3016603542
- 1123137
- 1000121375
- 3014579161
- 3010155648
- 3019843904
- 3016851379
- 3010160527
- 3012535730
- 1018120
- 3017552041
- 9680455
- 3013521734
- 3036978602
- 2435946
- 3017509841
- 1060680
- 3030926959
- 3017297225
- 3043226252
- 3016450032
- 1225532
- 3038550164
- 3024856793
- 8030128
- 3011689956
- 3002907620
- 3004637474
- 3013820501
- 1055236
- 3016807311
- 3009610508
- 3010034780
- 1819174
- 3010131715
- 3014146451
- 3007605720
- 3004170064
- 3035479692
- 3010132111
- 1319660
- 1929833
- 1417519
- 3031841433
- 3005113244
- 3012494290
- 3042272797
- 3009655869
- 1048735
- 1424524
- 3009756327
- 1420032
- 3010770024
- 2280705
- 3012448339
- 3042953785
- 1719513
- 3039169663
- 3006498370
- 2218158
- 1034876
- 3006785496
- 3027590916
- 3011191255
- 3031180770
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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