510(k) K243001
- Device
- Sterile Water USP and Sterile 0.9% Normal Saline USP
- Applicant
- Laboratorios Biogalenic S.A. DE C.V.
- 510(k) number
- K243001
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-06
- Date received
- 2024-09-26
- Classification name
- Dressing, Wound, Drug
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Roberto Quiñonez
- Address
- Calle Claper, Blvd. Del Ejercito Nacional Km 5.5, Soyapango, San Salvador SV 1639 1639
FDA Registration Numbers
- 1450662
- 3013820501
- 3030926959
- 2029412
- 3010131715
- 1025483
- 3036978602
- 1043549
- 3015547002
- 2183744
- 3010610560
- 3013188547
- 3007007790
- 9614157
- 3009504230
- 3007048057
- 3011210302
- 1319660
- 3006984486
- 1423537
- 3027529701
- 3019944216
- 3042953785
- 3032911850
- 1064858
- 3002807314
- 3009756327
- 3016603542
- 3012535730
- 3033536319
- 2954718
- 3004530184
- 3019543072
- 3005694677
- 3005669815
- 3007594734
- 3014635301
- 3007966889
- 9681630
- 3017509841
- 3012629741
- 3015282703
- 3042272797
- 3005533873
- 3004681519
- 3007663067
- 3009167225
- 3010315629
- 3014579161
- 3008808082
- 9610825
- 3005920706
- 1061927
- 3018348
- 3009134884
- 3014146451
- 3024856793
- 3012111117
- 9615014
- 3038550164
- 3009931872
- 1831301
- 3014258951
- 1819174
- 3016761372
- 3009848807
- 3006052875
- 8010690
- 3012907824
- 3016807311
- 3017396949
- 3008750913
- 1314417
- 3007841320
- 2029275
- 3021784063
- 1048735
- 3030692786
- 2431014
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 |