UTC 3mL Medication Cartridge
FDA 510(k) K230718 · Gilero, LLC
510(k) numberK230718
Submission
- Device name
- UTC 3mL Medication Cartridge
- Applicant
- Gilero, LLC
Morrisville, NC, US - Received
- March 15, 2023
- Decision date
- June 15, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRZ – Accessories, Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code MRZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220695 | Elite Biomedical Solutions Dose Request CordMRZ · Traditional | Elite Biomedical Solutions | 04/29/2022SE |
| K201634 | RG 3ml Medication CartridgeMRZ · Traditional | Chengdu Shifeng Medical Technology Co., Ltd. | 03/26/2021SE |
| K193654 | BlueStar RxMRZ · Traditional | Welldoc, Inc. | 04/07/2020SE |
| K191910 | SpaceStation MRIMRZ · Traditional | B. Braun Melsugen AG | 03/12/2020SE |
| K190013 | WellDoc BlueStarMRZ · Traditional | Welldoc, Inc. | 11/04/2019SE |
| K173531 | Lockbox for Perfusor Space PCA Infusion PumpMRZ · Traditional | B.Braun Medical, Inc. | 08/02/2018SE |
| K171346 | Sapphire SetsMRZ · Traditional | Icu Medical | 08/25/2017SE |
| K162532 | WellDoc BlueStar, WellDoc BlueStar RxMRZ · Traditional | Welldoc, Inc. | 01/12/2017SE |
| K160492 | Hospira Sapphire SetsMRZ · Traditional | Hospira, Inc. | 12/06/2016SE |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemMRZ · Traditional | Welldoc, Inc. | 11/22/2016SE |
More from Welldoc, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLKPE · Traditional | 05/06/2021SE |
Questions and answers
When was UTC 3mL Medication Cartridge cleared by the FDA?
UTC 3mL Medication Cartridge (K230718) received a 510(k) decision of Substantially Equivalent on June 15, 2023, 92 days after the submission was received.
What is the product code of K230718?
The FDA product code is MRZ – Accessories, Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.