SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE— 510(k) K132681
Substantially EquivalentSol-Millennium Medical, Inc.
FDA 510(k) clearance K132681 for SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE, Substantially Equivalent on 2014-05-22. Applicant: Sol-Millennium Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sol-Millennium Medical, Inc.
- Product code
- Code MEG
- 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 MEG
view allMore clearances from Sol-Millennium Medical, Inc.
view all- K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray
- K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
- K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
- K242291 — SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle
- K242099 — Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle
Adverse events under product code MEG
product code MEG- Malfunction
- 1,373
- Other
- 1
- Total
- 1,374
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.