INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES— 510(k) K081436
Substantially EquivalentInviro Medical Devices, Inc.
FDA 510(k) clearance K081436 for INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES, Substantially Equivalent on 2008-10-22. Applicant: Inviro Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Inviro Medical Devices, 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
- Traditional
- Location
- Lawrenceville, GA, US
Recent devices under product code FMF
view allMore clearances from Inviro Medical Devices, Inc.
view all- K101359 — INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)
- K092413 — INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES
- K092430 — 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES
- K083851 — INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022
- K071307 — INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003
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.