Niplette
FDA 510(k) K952035 · Avent America, Inc.
510(k) numberK952035
Submission
- Device name
- Niplette
- Applicant
- Avent America, Inc.
Addison, IL, US - Received
- May 1, 1995
- Decision date
- July 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HGY – Pump, Breast, Non-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.5150
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101538 | Handheld Manual Breast Pump (Avent Manual Breast Pump)HGY · Traditional | Philips Electronics UK Limited | 11/05/2010SE |
| K032845 | Easy Comfort Deluxe Manual Breast Pump, Model 1187HGY · Traditional | The First Years, Inc. | 04/05/2004SE |
| K013226 | Evenflo Comfort Ease Manual Breast Pump KitHGY · Traditional | Evenflo Company, Inc. | 12/20/2001SE |
| K011519 | Ameda HygienikitHGY · Traditional | Hollister, Inc. | 08/15/2001SE |
| K971231 | White River Mini Manual Breast PumpHGY · Traditional | White River Concepts | 05/19/1997SE |
| K962828 | Evert-ItHGY · Traditional | Genesis Industries, Inc. | 02/10/1997SE |
| K952034 | Medela's Foot PumpHGY · Traditional | Medela, Inc. | 09/12/1995SE |
| K925738 | White River Manual Breast PumpHGY · Traditional | White River (Tm) | 05/04/1994SE |
| K912355 | Mothers Touch One Hand Breast PumpHGY · Traditional | Hollister, Inc. | 12/10/1993SE |
| K902552 | Gerber Precious Care Electric Breast PumpHGY · Traditional | Gerber Products Co. | 09/26/1990SE |
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Questions and answers
When was Niplette cleared by the FDA?
Niplette (K952035) received a 510(k) decision of Substantially Equivalent on July 28, 1995, 88 days after the submission was received.
What is the product code of K952035?
The FDA product code is HGY – Pump, Breast, Non-Powered, a Class I (low risk) device regulated under 21 CFR 884.5150.