Bernsco Electrosurgical Shield
by Bernsco Surgical Supply, Inc.
510(k) K883823
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883823 | Date4 Oct 1988 | 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- Withdrawn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 Bernsco Electrosurgical Shield is a protective device designed to isolate and safeguard tissue during electrosurgical procedures. It is classified as a general surgical accessory intended to prevent unintended electrical current dispersion, thereby reducing the risk of collateral tissue damage or burns. Constructed from plastic, it features a handle for precise placement and positioning around sensitive areas during surgery. Its design aligns with electrosurgical accessories used in cutting and coagulation applications.
This device is supplied as a single-use item, intended for use in sterile surgical settings. It is not MRI-compatible and must be handled with sterile technique before application. The shield measures approximately 23.5 x 21.5 mm and is reusable for approximately 50 autoclave cycles, as per manufacturer guidelines. Authorized under FDA 510(k) clearance (K883823), it adheres to regulatory standards for electrosurgical accessories in general and plastic surgery applications.
Other devices from Bernsco Surgical Supply, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Bernsco Electrosurgical Shield used for?
The Bernsco Electrosurgical Shield is designed to protect sensitive tissue during electrosurgical procedures, such as cutting or coagulation. By isolating the area, it prevents unintended electrical current dispersion, which can cause collateral tissue damage or burns. This makes it particularly useful in surgeries where precision and safety around delicate tissues are critical.
Is the Bernsco Electrosurgical Shield single-use or reusable?
The device is intended for single-use in sterile surgical settings, but it is also rated for reuse through up to 50 autoclave cycles as per the manufacturer’s guidelines. This allows for extended use in controlled environments where sterilization protocols are strictly followed.
What are the dimensions and handling requirements of the shield?
The shield measures approximately 23.5 mm by 21.5 mm and features a handle for precise placement. Due to its single-use intent, it must be handled using sterile technique before application to maintain surgical sterility and prevent contamination.
Can the Bernsco Electrosurgical Shield be used in MRI environments?
No, the shield is explicitly labeled as not MRI-compatible. This means it should not be used in magnetic resonance imaging environments, as the electromagnetic fields could interfere with the device or pose safety risks.
What regulatory clearance does the Bernsco Electrosurgical Shield hold?
The device holds FDA 510(k) clearance under the reference number K883823, with a classification as substantially equivalent to predicate devices. This clearance is specific to its use as a general surgical accessory for electrosurgical procedures, including plastic surgery applications.