INUMI Flex Needle
FDA 510(k) K233884 · Galvanize Therapeutics, Inc.
510(k) numberK233884
Submission
- Device name
- INUMI Flex Needle
- Applicant
- Galvanize Therapeutics, Inc.
Redwood City, CA, US - Received
- December 8, 2023
- Decision date
- May 22, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAB – Low Energy Direct Current Thermal Ablation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Ablation of soft tissue
Other 510(k)s with product code OAB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253846 | Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…OAB · Traditional | Hangzhou Ruidi Biotechnology , Ltd. | 08/12/2026SE |
| K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex NeedleOAB · Traditional | Galvanize Therapeutics, Inc. | 05/07/2026SE |
| K253198 | NanoKnife Generator (H78720300351US0)OAB · Traditional | Angiodynamics | 03/24/2026SE |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…OAB · Traditional | AngioDynamics, Inc. | 12/06/2024SE |
| K240376 | Electroporation System (N3000)OAB · Traditional | Surgnova Healthcare Technologies (Zhejiang) Co.… | 10/04/2024SE |
| K240297 | Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)OAB · Traditional | Us Medical Innovations, LLC | 05/03/2024SE |
| K222001 | Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeOAB · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 06/08/2023SE |
| K212871 | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) ElectrodeOAB · Traditional | Galvanize Therapeutics, Inc. | 06/17/2022SE |
| K183385 | NanoKnife SystemOAB · Traditional | Angiodynamics | 06/18/2019SE |
| K150089 | NanoKnife SystemOAB · Traditional | AngioDynamics, Inc. | 06/18/2015SE |
More from AngioDynamics, Inc.
Questions and answers
When was INUMI Flex Needle cleared by the FDA?
INUMI Flex Needle (K233884) received a 510(k) decision of Substantially Equivalent on May 22, 2024, 166 days after the submission was received.
What is the product code of K233884?
The FDA product code is OAB – Low Energy Direct Current Thermal Ablation System, a Class II (moderate risk) device regulated under 21 CFR 878.4400.