Reverso Pro System

Q: When was Reverso Pro System cleared by the FDA?

Reverso Pro System (K243139) received a 510(k) decision of Substantially Equivalent on January 22, 2025, 114 days after the submission was received.

Q: What is the product code of K243139?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.

FDA 510(k) K243139 · Indiba S. A. U.

Substantially Equivalent

510(k) numberK243139

Submission

Device name: Reverso Pro System
Applicant: Indiba S. A. U.
Sant Quirze Del Vallès (Barcelona), ES
Received: September 30, 2024
Decision date: January 22, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GEI – Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4400
Specialty: General, Plastic Surgery

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).

Other 510(k)s with product code GEI

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K253859	Scarlet Pro (Scarlet Pro)GEI · Traditional	VIOL Co., Ltd.	08/27/2026SE
K252535	Inno-Switch Laparoscopic InstrumentsGEI · Traditional	Taiwan Surgical Corporation	08/25/2026SE
K261179	AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional	Gimmi GmbH	07/22/2026SE
K253504	VolnewmerGEI · Traditional	Classys, Inc.	07/13/2026SE
K254056	THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional	Olympus Medical Systems Corp.	07/01/2026SE
K253484	Lutronic GeniusGEI · Traditional	Cynosure Lutronic Technology Corporation	06/29/2026SE
K251492	Irrigation Tubing Bipolar Cord SetGEI · Traditional	New Deantronics Taiwan , Ltd.	06/29/2026SE
K260636	Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional	Stryker Sustainability Solutions	06/18/2026SE

510(k)	Device	Decision
K241107	Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba…PBX · Traditional	01/24/2025SE
K243164	INDIBA COMPACT devicesPBX · Traditional	11/20/2024SE

Questions and answers

When was Reverso Pro System cleared by the FDA?

Reverso Pro System (K243139) received a 510(k) decision of Substantially Equivalent on January 22, 2025, 114 days after the submission was received.

What is the product code of K243139?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.