GEI · Electrosurgical, Cutting & Coagulation & Accessories

Device class

Class II

Regulation 878.4400

Total clearances

371

2020-01-07 → 2026-07-22

Last 12 months

Unique sponsors

178

Definition

What is Electrosurgical, Cutting & Coagulation & Accessories

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4400

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Livsmed, Inc.	11	1	2025-10-21
ArthroCare Corporation	8	2	2026-03-30
InMode , Ltd.	8	1	2026-01-15
Covidien, LLC	8	0	2024-07-12
BTL Industries, Inc.	8	1	2026-03-17
ShenB Co., Ltd.	8	0	2025-03-19
Pulse Biosciences, Inc.	7	0	2024-08-05
Erbe Elektromedizin GmbH	7	2	2025-12-18
Agnes Medical Co., Ltd.	6	1	2025-09-03
Ethicon Endo-Surgery	5	0	2023-04-13
Starmed Co., Ltd.	5	2	2026-05-26
Olympus Winter & Ibe GmbH	5	1	2025-09-23
Applied Medical Resources Corporation	5	2	2025-11-04
Conmed Corporation	5	0	2023-10-23
New Deantronics Taiwan , Ltd.	5	2	2026-06-29
Bolder Surgical, LLC	5	0	2023-11-15
Pollogen, Ltd.	5	1	2025-09-12
Hironic Co., Ltd.	5	2	2026-04-06
Jeisys Medical, Inc.	5	0	2024-12-10
Inbella Medical, Inc.	5	2	2026-01-27
Ilooda Co,., Ltd.	4	0	2024-11-21
Neurent Medical	4	1	2026-06-16
Apyx Medical Corporation	4	0	2023-06-09
Aerin Medical, Inc.	4	1	2026-05-18
Soniquence, LLC	4	1	2026-01-27

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
99070	CPT	—	Medium	Electrosurgical device accessories typically billed as surgical supplies with electrosurgery procedure code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-22	K261179	Gimmi GmbH	AlphaTriPart - Monopolar MIC Instruments
2026-07-13	K253504	Classys, Inc.	Volnewmer
2026-07-01	K254056	Olympus Medical Systems Corp.	THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)
2026-06-29	K253484	Cynosure Lutronic Technology Corporation	LUTRONIC GENIUS
2026-06-29	K251492	New Deantronics Taiwan , Ltd.	Irrigation Tubing Bipolar Cord Set
2026-06-18	K260636	Stryker Sustainability Solutions	Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
2026-06-17	K253634	Hologic, Inc.	CoolSeal Generator® (CSL-200-90)
2026-06-16	K261833	Neurent Medical , Ltd.	NEUROMARK System (NMK00301)
2026-06-09	K253165	Sejong Medical Co., Ltd.	LAP-iX2N
2026-06-05	K253656	Medtronic Sofamor Danek USA, Inc.	OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
2026-06-02	K253918	F Care Systems USA, LLC	Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
2026-06-02	K253803	Lumenis Be, Ltd.	MILAN System
2026-05-29	K261202	Entire Medical , Ltd.	ENTire IRE System
2026-05-26	K252833	Starmed Co., Ltd.	VIVA combo RF System
2026-05-20	K253134	Lagis Enterprise Co., Ltd.	LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
2026-05-18	K260522	Aerin Medical, Inc.	RhinAer+ Stylus
2026-04-10	K253917	Plasma Surgical, Inc.	ARION ARC System
2026-04-10	K253777	Ascblue Corporation	Ascblue (8010)
2026-04-07	K260466	Zhejiang shuyou Surgical Instrument Co., Ltd.	Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)
2026-04-06	K260397	Hironic Co., Ltd.	SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)
2026-04-01	K253405	Prana Surgical	Prana System
2026-03-30	K254122	ArthroCare Corporation	FLOW FLEXTEND Wand (72290039)
2026-03-27	K260255	Aventix Medical, Inc.	AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)
2026-03-25	K253680	ArthroCare Corporation	LYNX COBLATION Laryngeal Wand (72290254)
2026-03-17	K253750	BTL Industries, Inc.	BTL-785NEH