Sol-Guard Auto-disable Syringe— 510(k) K220713
Substantially EquivalentSol-Millennium Medical, Inc.
FDA 510(k) clearance K220713 for Sol-Guard Auto-disable Syringe, Substantially Equivalent on 2023-05-04. Applicant: Sol-Millennium Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sol-Millennium Medical, 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
- Suwanee, GA, US
Recent devices under product code FMF
view allMore clearances from Sol-Millennium Medical, Inc.
view all- 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
- K241821 — Luer Lock Syringe with Safety Needle +2 more
- K222744 — Sol-M Luer Lock Syringe
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.