Medela Low Dose Enteral Syringe— 510(k) K161811
Substantially EquivalentMedela, Inc.
FDA 510(k) clearance K161811 for Medela Low Dose Enteral Syringe, Substantially Equivalent on 2017-02-15. Applicant: Medela, Inc.. Device class: 2.
Clearance details
- Applicant
- Medela, Inc.
- Product code
- Code PNR
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Recent devices under product code PNR
view allMore clearances from Medela, Inc.
view all- K161725 — Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
- K031614 — MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
- K020518 — MEDELA SYMPHONY BREAST PUMP, MODEL 024
- K984589 — PHOTOTHERAPY LAMP
- K983552 — BASIC, MEDIAN, DOMINANT, AND VARIO
Adverse events under product code PNR
product code PNR- Other
- 6
- Total
- 6
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 →
Recalls naming K161811
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161811.
Data sourced from openFDA. This site is unofficial and independent of the FDA.