Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump— 510(k) K182749
Substantially EquivalentLansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.
FDA 510(k) clearance K182749 for Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump, Substantially Equivalent on 2019-06-12. Applicant: Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.. Device class: 2.
Clearance details
- Applicant
- Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.
- Product code
- Code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cigli, TR
Recent devices under product code HGX
view all- K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more
- K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
- K260643 — Cimilre Dual Max
- K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
- K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3)
Adverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.