← Back to catalogue
American Surgical Company/ Neurosurgical Sponges (brand)
FDA 510(k)Class II (US FDA 510(k))
510(k) K112598
Identifiers
- 510(k) Number
- K112598 FDA 510(k)
- FDA Product Code
- HBA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4700 FDA 510(k)
- Regulation Number
- 882.4700 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
American Surgical Company/ Neurosurgical Sponges (brand) by American Surgical Company, LLC — Class II — FDA_510K — listed in FDA 510(k)
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 | K112598 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- American Surgical Company, LLC
Sources (1)
- FDA 510(k) K112598 24 fields · synced Jun 18, 2026