INJECTRITE-C15 AND INJECTRITE-C30— 510(k) K002127
Substantially EquivalentSterling Medivations, Inc.
FDA 510(k) clearance K002127 for INJECTRITE-C15 AND INJECTRITE-C30, Substantially Equivalent on 2000-12-29. Applicant: Sterling Medivations, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterling Medivations, Inc.
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Wayzata, MN, US
Recent devices under product code FMF
view allMore clearances from Sterling Medivations, Inc.
view all- K021530 — SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
- K021487 — SIMPLICITY EASY ACCESS P INFUSION SET
- K021296 — SIMPLICITY QD EASY P INFUSION SET
- K021216 — SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS
- K021005 — SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
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.