ENFit Reusable Enteral Syringe— 510(k) K203613
Substantially EquivalentShantou Wealy Medical Instrument Co.,Ltd
FDA 510(k) clearance K203613 for ENFit Reusable Enteral Syringe, Substantially Equivalent on 2021-08-27. Applicant: Shantou Wealy Medical Instrument Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Shantou Wealy Medical Instrument Co.,Ltd
- Product code
- Code PNR
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shantou, CN
Recent devices under product code PNR
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
- K203410 — ENFit Disposable Enteral Syringe
- K141640 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
- K113587 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)
Adverse events under product code PNR
product code PNR- Other
- 6
- Total
- 6
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.