Saline Enhanced Electrosurgical Resection (SEER) Device

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

510(k) Number

K082568 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Bovie Resistick II Coated Electrosurgical Electrodes

  Class II

  FDA 510(k) K093025 Active Cleared 22 Dec 2009

• Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip)

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  FDA 510(k) K121441 Active Cleared 20 Jul 2012

• Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces

  Class II

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• Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator

  Class II

  FDA 510(k) K170188 Active Cleared 8 Mar 2017

• Bovie J-Plasma Precise 360 Handpiece

  Class II

  FDA 510(k) K152570 Active Cleared 2 Nov 2015

• Boss Coagulation Device, Model BOSS1215, Boss Coagulation Device, Angled Access, Model BOSA1215

  Class II

  FDA 510(k) K092149 Active Cleared 18 Mar 2010

See all devices from Bovie Medical Corporation →

• What types of surgical procedures is the SEER Device designed to assist with, and how does the saline irrigation feature improve precision during use?

  The SEER Device is designed for tissue resection, cutting, and coagulation in surgical settings, particularly within general and plastic surgery applications. The saline irrigation feature enhances precision by reducing thermal damage to surrounding tissues, allowing for cleaner cuts and better control during electrosurgical procedures. This combination of energy delivery and irrigation helps minimize collateral effects, making it useful for delicate resections.

• Is the SEER Device intended for reuse, or is it meant to be used only once? How does this impact its handling and disposal?

  The SEER Device is explicitly designed for single-use in surgical settings. This means it should not be reused after a single procedure, as reuse could compromise sterility and performance. Clinicians should follow standard single-use medical device protocols for handling, including proper disposal after use to ensure patient safety and compliance with infection control guidelines.

• What electrosurgical generator is required to operate the SEER Device, and are there any specific compatibility considerations?

  The SEER Device requires pairing with an electrosurgical generator compatible with saline-enhanced electrosurgery. While the device itself is not a generator, its design assumes integration with a system capable of delivering controlled electrosurgical energy alongside saline irrigation. Users should verify compatibility with their existing generator to ensure optimal performance and safety during procedures.

• How is sterility maintained for the SEER Device, and what storage instructions should be followed to preserve its integrity?

  The SEER Device is sterile for surgical use as packaged, ensuring readiness for immediate application in the operating room. To maintain sterility, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Once opened, the device must be used promptly, and any unused portions should be discarded per single-use medical device protocols.

• Are there multiple sizes or models of the SEER Device, or is it available in a single configuration?

  The provided data does not specify multiple sizes or models for the SEER Device, implying it is likely offered in a standard configuration for general electrosurgical resection tasks. For exact specifications (e.g., blade length, shaft diameter), clinicians should refer to the manufacturer’s product documentation or contact Bovie Medical directly, as variations may exist for different surgical applications.