MODO DUO Electric Pump (B11621, B11673)— 510(k) K261782
Substantially EquivalentTomy International, Inc.
FDA 510(k) clearance K261782 for MODO DUO Electric Pump (B11621, B11673), Substantially Equivalent on 2026-10-16. Applicant: Tomy International, Inc.. Device class: 2.
Clearance details
- Applicant
- Tomy International, Inc.
- Product code
- Product 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
- Dyersville, IA, US
Recent devices under product code HGX
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- 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
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.