Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
FDA 510(k) clearance K161623 · decided 2016-11-10
Clearance details
- K-number
- K161623
- Device name
- Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-06-13
- Decision date
- 2016-11-10
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Allentown, PA, US
- Third-party review
- No
- Expedited review
- No
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| Promogran Prisma™ Collagen Matrix with ORC and Silver (K251999) | Solventum Germany GmbH | 2026-03-13 |
| LUOFUCON® Antimicrobial Wound Gel (K252028) | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| Redermax Antibacterial Wound Matrix (K251582) | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| New Day Skin Spray (K252568) | Silk Holdings, Inc. | 2026-01-23 |
| SBC1 Cream (K250890) | Sioxmed, LLC | 2026-01-12 |
| revyve® Antimicrobial Skin and Wound Cleanser (K252759) | Kane Biotech, Inc. | 2026-01-08 |
Recalls involving this device
No recalls on record reference this clearance.