SALINE WOUND WASH
FDA 510(k) clearance K112666 · decided 2012-04-20
Clearance details
- K-number
- K112666
- Device name
- SALINE WOUND WASH
- Applicant
- Nanoplas, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-09-13
- Decision date
- 2012-04-20
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Elk Grove Village, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% S recall (Z-1431-2026) | Medline Industries, LP | 2026-02-20 |
| Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214 recall (Z-1432-2026) | Medline Industries, LP | 2026-02-20 |
| Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT recall (Z-1433-2026) | Medline Industries, LP | 2026-02-20 |
| Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 recall (Z-1434-2026) | Medline Industries, LP | 2026-02-20 |
| Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1 recall (Z-1435-2026) | Medline Industries, LP | 2026-02-20 |