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Irrisept Antimicrobial Wound Lavage
FDA 510(k)FDA UDIClass II (US FDA 510(k))
510(k) K210536
Identity
- Trade Name
- Irrisept Antimicrobial Wound Lavage FDA UDI
- Generic Name
- Pressure-regulated wound irrigation solution applicator, manual FDA UDI
- Device Name
- 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator. FDA UDI
- Model / Reference
- ISEPT-150-USA FDA UDI
- Description
- 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10842351120009 FDA UDI
- 510(k) Number
- FDA Product Code
- FQH FDA 510(k)FDA UDIFRO FDA UDI
- GMDN Term
- Pressure-regulated wound irrigation solution applicator, manual FDA UDI
Classification
- Device Class
- Class II FDA 510(k)U FDA UDI
- Legislation / Framework
- 21 CFR Part 880.5475 FDA 510(k)
- Regulation Number
- 880.5475 FDA 510(k)FDA UDI
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 150 Milliliter FDA UDI
Irrisept Antimicrobial Wound Lavage by Irrimax Corporation — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210536 | Class II | Active |
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Manufacturer
- Manufacturer
- Irrimax Corporation
Sources (2)
- FDA 510(k) K210536 24 fields · synced Jun 18, 2026
- FDA UDI c583942f-1eb7-47cb-a40f-1367483ea0c1 37 fields · synced May 27, 2026