INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)— 510(k) K101359
Substantially EquivalentInviro Medical Devices, Inc.
FDA 510(k) clearance K101359 for INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML), Substantially Equivalent on 2010-08-20. 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
- Special
- Location
- Lawrenceville, GA, US
Recent devices under product code FMF
view allMore clearances from Inviro Medical Devices, Inc.
view all- 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
- K081436 — INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES
- 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 →
Recalls naming K101359
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 K101359.
Data sourced from openFDA. This site is unofficial and independent of the FDA.