New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.
by New Deantronics Taiwan, Ltd.
510(k) K152031
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152031 | Date17 Sep 2015 | 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- Withdrawn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
- FDA applicant
- New Deantronics Taiwan , Ltd.
- 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 New Deantronics Smoke Evacuation Adapter and Button Switch Electrosurgical Pencil Adapters are designed as accessories for electrosurgical instruments. The Smoke Evacuation Adapters attach to electrosurgical pencils to improve surgical visibility by evacuating smoke and odors directly at the surgical site when connected to a smoke evacuator. The Button Switch Electrosurgical Pencil Adapters integrate with electrosurgical pencils, enabling compatibility with specific adapters (SA01, SA02) for enhanced functionality during surgical procedures.
These adapters are intended for use in surgical settings, where they connect to electrosurgical devices and smoke evacuators. Supplied as reusable medical devices, they are regulated under FDA 510(k) clearance (K152031) and classified under product code GEI. The adapters are not sterile and must be cleaned and maintained according to manufacturer guidelines. No specific MRI safety information is provided, and sizes are determined by the connector type (10mm, 22mm, SA01, SA02).
Other devices from New Deantronics Taiwan, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What are the New Deantronics Smoke Evacuation Adapters used for?
The New Deantronics Smoke Evacuation Adapters are designed to attach to electrosurgical pencils and connect to a smoke evacuator. Their primary purpose is to enhance surgical visibility by removing smoke and odors directly at the surgical site during procedures, ensuring a clearer field of view for the surgeon.
Are these adapters single-use or reusable?
These adapters are reusable medical devices. They are not intended for single-use and must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and hygiene.
What connector types are available for the Smoke Evacuation Adapters?
The Smoke Evacuation Adapters come in two connector types: 10mm and 22mm. The size of the connector determines compatibility with specific electrosurgical devices and smoke evacuators, so selecting the correct type is essential for proper use.
Are the New Deantronics Button Switch Electrosurgical Pencil Adapters sterile?
No, the New Deantronics Button Switch Electrosurgical Pencil Adapters (SA01, SA02) are not supplied sterile. They are reusable devices and must be cleaned and processed according to the manufacturer’s instructions before each use to maintain sterility and functionality.
What regulatory clearance do these adapters hold?
These adapters are cleared under the FDA’s 510(k) pathway with clearance number K152031. They are classified under product code GEI and are intended for use in surgical settings where electrosurgical procedures are performed.