510(k) clearance
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)
- 510(k) number
- K261622
- Applicant
- Philips Consumer Lifestyle B.V.
- Decision date
- Sep 3, 2026
- Date received
- May 15, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HGX
- Device type
- Pump, Breast, Powered
- Device class
- Class II
- Regulation
- 21 CFR 884.5160
- Advisory committee
- Obstetrics/Gynecology
- Statement or summary
- Summary
- Third party
- N
- Location
- Drachten, NL