Tonsil Sponges 50-00
by American Surgical Company, LLC
Tonsil Sponges 50-00 is a dissection sponge (FDA unclassified; FDA product code EFQ, Gauze/Sponge, Internal) made by American Surgical Company, LLC, cleared under FDA 510(k) K872806 on 4 Aug 1987 and listed in FDA GUDID since 30 Jun 2016 (UDI-DI 20749915000746), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number20749915000746 | Date30 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK872806 | Date4 Aug 1987 | StatusActive |
Official records
- AccessGUDID record 20749915000746
- FDA 510(k) database K872806
Across registries
- FDA 510(k) K872806 decided 4 Aug 1987 Active
- FDA GUDID UDI-DI 20749915000746 listed 30 Jun 2016 Listed
Recalls
-
- Terminated Z-1763-2016
Product packaging defective compromising sterility
Timeline
- Cleared FDA 510(k) K872806
- Recall initiated FDA recalls Z-1763-2016
- Listed FDA GUDID 20749915000746
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tonsil Sponges
- Generic name
- Dissection sponge
- Model / reference
- 50-00
- Primary DI / UDI-DI
- 20749915000746
- 510(k) Number
- FDA product code
- EFQ
- GMDN term
- Dissection sponge
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
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- ISOLYER (4X4, 12 PLY) by Thantex Specialties, Inc.