510(k) K261622
K261622 is an FDA 510(k) premarket notification submitted by Philips Consumer Lifestyle B.V. for the device "Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)". The FDA issued a decision of Substantially Equivalent on September 3, 2026. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Philips Consumer Lifestyle B.V. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 2026
- Date Received
- May 15, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Breast, Powered
- Device Class
- Class II
- Regulation Number
- 884.5160
- Review Panel
- OB
- Submission Type