AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE— 510(k) K141640
Substantially EquivalentShantou Wealy Medical Instrument Co.,Ltd
FDA 510(k) clearance K141640 for AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE, Substantially Equivalent on 2014-11-19. Applicant: Shantou Wealy Medical Instrument Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Shantou Wealy Medical Instrument Co.,Ltd
- 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
- Lafayette, CA, US
Recent devices under product code MEG
view allMore clearances from Shantou Wealy Medical Instrument Co.,Ltd
view all- K222452 — Disposable Automatically Retractable Safety Syringes (with detachable needle)
- K210216 — Disposable Automatically Retractable Insulin Safety Syringe
- K203613 — ENFit Reusable Enteral Syringe
- K203410 — ENFit Disposable Enteral Syringe
- K113587 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED 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.