V-GO INSULIN DELIVERY SYSTEM— 510(k) K103825
Substantially EquivalentValeritas, Inc.
FDA 510(k) clearance K103825 for V-GO INSULIN DELIVERY SYSTEM, Substantially Equivalent on 2011-02-23. Applicant: Valeritas, Inc.. Device class: 2.
Clearance details
- Applicant
- Valeritas, Inc.
- Product code
- Code LZG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shrewsbury, MA, US
Recent devices under product code LZG
view allAdverse events under product code LZG
product code LZG- Death
- 104
- Injury
- 12,022
- Malfunction
- 135,004
- Other
- 1
- Total
- 147,131
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 K103825
K-number listed on FDA's recall record- Z-0195-2020 — DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03
- Z-0196-2020 — DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02
- Z-0197-2020 — DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
- Z-0198-2020 — DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03
- Z-0199-2020 — DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103825.
Data sourced from openFDA. This site is unofficial and independent of the FDA.