E2590 - B, Argon Accessory with Blade Electrode and E2590 - N, Argon Accessory with Needle Electrode

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K962690 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Valleylab, Inc. →

• What are the E2590-B and E2590-N argon accessories used for?

  These accessories are designed for argon-enhanced electrosurgery within monopolar systems. The E2590-B features a blade electrode, while the E2590-N uses a needle electrode. Both deliver argon gas around the electrode to enhance tissue effects, improving control and efficiency during open surgical cutting and coagulation procedures.

• Are the E2590-B and E2590-N argon accessories intended for single-use or reuse?

  These devices are explicitly intended for single-use in sterile surgical environments. Their design and classification as electrosurgical accessories align with disposable medical device standards to ensure patient safety and sterility.

• How do the blade and needle electrodes differ in application?

  The E2590-B argon accessory with a blade electrode is optimized for cutting and precise tissue dissection, while the E2590-N argon accessory with a needle electrode is suited for targeted coagulation or hemostasis in confined areas. Both leverage argon gas to enhance their respective effects.

• What regulatory clearance do the E2590-B and E2590-N argon accessories hold?

  These accessories are cleared under the FDA 510(k) pathway (K962690) as substantially equivalent to a predicate device. They fall under the GEI product code for electrosurgical cutting and coagulation accessories, adhering to Class II regulatory standards.

• Do these argon accessories require special storage or handling?

  As single-use devices, the E2590-B and E2590-N argon accessories should be stored in their original, sealed packaging to maintain sterility until use. Avoid exposure to moisture, extreme temperatures, or contamination, as this could compromise their performance or integrity.