Endotool Drug Dose Calculator
FDA 510(k) K053137 · MD Scientific, LLC
510(k) numberK053137
Submission
- Device name
- Endotool Drug Dose Calculator
- Applicant
- MD Scientific, LLC
Charlotte, NC, US - Received
- November 9, 2005
- Decision date
- June 14, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDC – Calculator, Drug Dose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
Other 510(k)s with product code NDC
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|---|---|---|---|
| K254102 | GlucommanderNDC · Traditional | Glytec, LLC | 05/27/2026SE |
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| K253281 | UpDocNDC · Traditional | Updoc, Inc. | 12/23/2025SE |
| K252104 | T1D1NDC · Traditional | Comerge AG | 08/20/2025SE |
| K241088 | EndoTool IV (3.1)NDC · Traditional | Monarch Medical Technologies | 12/11/2024SE |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android))NDC · Traditional | Medtronic Minimed | 11/12/2024SE |
| K242066 | iSage RxNDC · Traditional | Amalgam Rx, Inc. | 08/21/2024SE |
| K232451 | Insulia Bolus CompanionNDC · Traditional | Voluntis Sa. | 12/12/2023SE |
| K230813 | BlueStar and BlueStar RxNDC · Traditional | Welldoc, Inc. | 07/28/2023SE |
Questions and answers
When was Endotool Drug Dose Calculator cleared by the FDA?
Endotool Drug Dose Calculator (K053137) received a 510(k) decision of Substantially Equivalent on June 14, 2006, 217 days after the submission was received.
What is the product code of K053137?
The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.