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Diathermic Snare (Cresent Type)

by Mill-Rose Laboratory

510(k) K792343

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792343 Date18 Dec 1979ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Diathermic Snare (Crescent Type) is a surgical instrument classified under the FDA product code GEI (General and Plastic Surgery). It is designed for electrosurgical tissue excision, utilizing diathermy to cut and coagulate tissue during procedures. The crescent-shaped snare allows precise control for removing or resecting targeted tissue while minimizing bleeding. This device is intended for use in controlled surgical environments where thermal cauterization is required.

This device is supplied as a reusable surgical instrument and is intended for single-user applications in sterile settings. It is not MRI-compatible and must be handled according to standard electrosurgical safety protocols. The device requires proper cleaning, sterilization, and storage to maintain functionality and prevent cross-contamination. Authorized for use in the United States under FDA 510(k) clearance (K792343), it adheres to regulatory standards for surgical instruments in general and plastic surgery applications.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Diathermic Snare (Crescent Type) used for?

    This device is designed for electrosurgical tissue excision, utilizing diathermy to cut and coagulate tissue during surgical procedures. The crescent shape allows for precise control when removing or resecting targeted tissue, helping to minimize bleeding in controlled surgical environments where thermal cauterization is required.

  • Is the Diathermic Snare (Crescent Type) reusable or single-use?

    The Diathermic Snare (Crescent Type) is supplied as a reusable surgical instrument. It is intended for single-user applications in sterile settings, meaning it should be cleaned, sterilized, and stored properly after each use to maintain functionality and prevent cross-contamination.

  • What safety protocols must be followed when using this device?

    This device is not MRI-compatible and must be handled according to standard electrosurgical safety protocols. Proper cleaning, sterilization, and storage are required to ensure its functionality and to prevent contamination. Always follow manufacturer guidelines for safe operation and maintenance.

  • How is the Diathermic Snare (Crescent Type) regulated in the U.S.?

    The device is authorized for use in the United States under FDA 510(k) clearance (K792343). It is classified under product code GEI for general and plastic surgery instruments and adheres to regulatory standards for surgical tools in those applications.

  • What storage requirements does the Diathermic Snare (Crescent Type) have?

    After use, the device must be thoroughly cleaned and sterilized before storage. It should be stored in a clean, dry environment, protected from moisture and physical damage, to maintain its integrity and ensure it remains ready for reuse in sterile surgical settings.