Ameda, Inc. 17093
by Ameda, Inc.
Ameda, Inc. 17093 is a Class I device made by Ameda, Inc., cleared under FDA 510(k) K912355 on 10 Dec 1993 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00810725020739), active as of 22 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 | Number00810725020739 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK912355 | Date10 Dec 1993 | StatusActive |
Official records
- AccessGUDID record 00810725020739
- FDA 510(k) database K912355
Across registries
- FDA 510(k) K912355 decided 10 Dec 1993 Active
- FDA GUDID UDI-DI 00810725020739 listed 24 Sep 2016 Listed
Recalls
-
- Terminated Z-1326-2015
Devices were not sterilized
Timeline
- Cleared FDA 510(k) K912355
- Recall initiated FDA recalls Z-1326-2015
- Listed FDA GUDID 00810725020739
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ameda, Inc.
- Generic name
- Breast pump, manual
- Model / Ref / Catalog
- 17093
- Primary DI / UDI-DI
- 00810725020739
- 510(k) Number
- FDA product code
- HGY
- GMDN term
- Breast pump, manual
- Device class
- Class I
- Regulation number
- 884.5150
- GUDID distribution status
- In Commercial Distribution
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