OAB · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2022-06-17 → 2026-08-12

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Galvanize Therapeutics, Inc.	3	1	2026-05-07
AngioDynamics, Inc.	2	1	2026-03-24
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.	1	0	2024-10-04
Hangzhou Ruidi Biotechnology , Ltd.	1	1	2026-08-12
Zhejiang Curaway Medical Technology Co., Ltd.	1	0	2023-06-08
Us Medical Innovations, LLC	1	0	2024-05-03

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
15788	CPT	—	Medium	Ablation/amputation, using electric cautery; soft tissue ablation code
17999	CPT	—	Medium	Unlisted dermatology code if low-energy DC ablation not otherwise categorized

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-12	K253846	Hangzhou Ruidi Biotechnology , Ltd.	Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02)
2026-05-07	K253826	Galvanize Therapeutics, Inc.	Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle
2026-03-24	K253198	Angiodynamics	NanoKnife Generator (H78720300351US0)
2024-12-06	K242687	AngioDynamics, Inc.	NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)
2024-10-04	K240376	Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.	Electroporation System (N3000)
2024-05-22	K233884	Galvanize Therapeutics, Inc.	INUMI Flex Needle
2024-05-03	K240297	Us Medical Innovations, LLC	Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)
2023-06-08	K222001	Zhejiang Curaway Medical Technology Co., Ltd.	Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
2022-06-17	K212871	Galvanize Therapeutics, Inc.	Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode

OAB · Unclassified

Clearance volume by quarter

Top sponsors in this product code

Likely billing codes (AI-inferred · verify with billing)

Most recent 510(k) clearances