ArmourSorb 88-05
by American Surgical Company, LLC
ArmourSorb 88-05 is a neurosurgical sponge (FDA Class II; FDA product code HBA, Neurosurgical Paddie) made by American Surgical Company, LLC, cleared under FDA 510(k) K112598 on 20 Jun 2013 and listed in FDA GUDID since 16 Jun 2016 (UDI-DI 20749915002351), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number20749915002351 | Date16 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112598 | Date20 Jun 2013 | StatusActive |
Official records
- AccessGUDID record 20749915002351
- FDA 510(k) database K112598
Across registries
- FDA 510(k) K112598 decided 20 Jun 2013 Active
- FDA GUDID UDI-DI 20749915002351 listed 16 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K112598
- Listed FDA GUDID 20749915002351
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ArmourSorb
- Generic name
- Neurosurgical sponge
- Model / reference
- 88-05
- Primary DI / UDI-DI
- 20749915002351
- 510(k) Number
- FDA product code
- HBA
- GMDN term
- Neurosurgical sponge
- Device class
- Class II
- Regulation number
- 882.4700
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HBA (Neurosurgical Paddie).
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- POLYESTER SPONGE PATTIE by American Silk Sutures, Inc.
- MEDLINE NEURO SPONGE by MEDLINE INDUSTRIES, INC.
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- ULTRACELL NEURO SPONGES by Ultracell Medical Technologies, Inc.
- NEUROLOGICAL SPONGE by I M, Inc.