Cleared Traditional

K233884 - INUMI™ Flex Needle (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233884 · Galvanize Therapeutics, Inc. · General & Plastic Surgery device
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May 2024
Decision
166d
Days
Class 2
Risk

K233884 is an FDA 510(k) clearance for the INUMI™ Flex Needle. Classified as Low Energy Direct Current Thermal Ablation System (product code OAB), Class II - Special Controls.

Submitted by Galvanize Therapeutics, Inc. (Redwood City, US). The FDA issued a Cleared decision on May 22, 2024 after a review of 166 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Galvanize Therapeutics, Inc. devices

Submission Details

510(k) Number K233884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2023
Decision Date May 22, 2024
Days to Decision 166 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 114d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAB Low Energy Direct Current Thermal Ablation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Ablation Of Soft Tissue
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OAB Low Energy Direct Current Thermal Ablation System

All 12
Devices cleared under the same product code (OAB) and FDA review panel - the closest regulatory comparables to K233884.
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Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
K222001 · Zhejiang Curaway Medical Technology Co., Ltd. · Jun 2023
Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
K212871 · Galvanize Therapeutics, Inc. · Jun 2022