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Electrocautery Shroud

FDA 510(k)

Class II (US FDA 510(k))

510(k) K930097

by I.C. Medical, Inc.

Identifiers

510(k) Number
K930097 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Electrocautery Shroud is a protective barrier designed for use with electrosurgical devices. It is classified under the FDA product code GEI as an accessory for electrosurgical procedures, intended to shield surrounding tissues and reduce the risk of thermal injury during cauterization.

This device is supplied as a single-use item and is intended for use in surgical settings where electrosurgical instruments are applied. It is regulated under the FDA’s 510(k) clearance (K930097) and falls under the classification name Electrosurgical (Regulation 878.4400). No additional sterility or MRI safety information is specified in the provided data.

Frequently asked questions

What is the Electrocautery Shroud used for?

The Electrocautery Shroud acts as a protective barrier during electrosurgical procedures. It is designed to shield adjacent tissues from unintended thermal injury caused by electrosurgical instruments, helping to minimize collateral damage while maintaining the precision of cauterization.

Is the Electrocautery Shroud reusable or single-use?

The Electrocautery Shroud is explicitly supplied as a single-use item. This design ensures sterility and safety for each surgical procedure, reducing the risk of cross-contamination or degradation between uses.

What regulatory clearance does the Electrocautery Shroud hold?

The device holds FDA 510(k) clearance under the reference number K930097. It is classified under the product code GEI as an accessory for electrosurgical procedures and is determined to be substantially equivalent to a legally marketed predicate device.

Does the Electrocautery Shroud require special storage conditions?

The provided data does not specify special storage requirements beyond standard surgical supply handling. As a single-use item, it should be stored in a clean, dry environment, protected from contamination and physical damage until use.

What materials is the Electrocautery Shroud made from?

The device is described as a plastic barrier, though the exact material composition is not detailed in the provided data. Its primary function is to provide a protective layer during electrosurgical procedures, ensuring safety for surrounding tissues.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K953418 FDA 510(k) - ELECTROCAUTERY SHROUD | I.C Medical, Inc., ELECTROCAUTERY SHROUD (K930097) — FDA 510 (k) | Innolitics, K930097 FDA 510(k) - ELECTROCAUTERY SHROUD | I.C Medical, Inc., ELECTROCAUTERY SHROUD (K953418) — FDA 510 (k) | Innolitics, ELECTROCAUTERY SHROUD 510 (k) K930097 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
I.C. Medical, Inc.
FDA Applicant
I.C Medical, Inc.

Sources (1)

  • FDA 510(k) K930097 24 fields · synced Oct 1, 2026