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Ameda, Inc. 17060

by Ameda, Inc.

Ameda, Inc. 17060 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 27 Sep 2016 (UDI-DI 00810725022351), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K912355

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810725022351 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK912355 Date10 Dec 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K912355 decided 10 Dec 1993 Active
  • FDA GUDID UDI-DI 00810725022351 listed 27 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1326-2015 FDA Class II initiated 12 Feb 2015

    Devices were not sterilized

Timeline

3 dated events

  1. Cleared FDA 510(k) K912355
  2. Recall initiated FDA recalls Z-1326-2015
  3. Listed FDA GUDID 00810725022351

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ameda, Inc.
Generic name
Breast pump, manual
Model / Ref / Catalog
17060
Primary DI / UDI-DI
00810725022351
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

Related devices

Category: Breast pump, manual

Cleared under the same submission (K912355)

and 6 more cleared under K912355

Similar devices

Other devices filed under FDA product code HGY (Pump, Breast, Non-Powered).

Other devices from Ameda, Inc.

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  • Ameda, Inc. 17115

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  • Ameda, Inc. 10002

    Class II

See all devices from Ameda, Inc. →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)