Diathermic Snare (Cresent Type)
510(k) K792343
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792343 | Date18 Dec 1979 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Mill-Rose Laboratory
Questions
AI-generated answers, 1 Oct 2026
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.