← Back to catalogue

Propencil ESU Pencil

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092732

by Bio Protech Inc.

Identifiers

510(k) Number
K092732 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 Propencil ESU Pencil is an electrosurgical pencil classified under product code GEI, designed for use in general surgical procedures. It delivers electrosurgical energy to the surgical site, enabling precise tissue cutting and coagulation during procedures.

This device is intended for single-use applications in controlled surgical environments. It has received FDA 510(k) clearance under the Substantial Equivalence (SESE) determination, with a K-number of K092732. The device is supplied sterile and is regulated under the General, Plastic Surgery advisory committee classification.

Frequently asked questions

What is the Propencil ESU Pencil used for in surgical procedures?

The Propencil ESU Pencil is designed for electrosurgical applications during general surgical procedures. It delivers focused energy to enable precise tissue cutting and coagulation, reducing bleeding and improving surgical control. This makes it ideal for procedures requiring fine manipulation, such as plastic or general surgery, where accuracy and minimal tissue damage are critical.

Is the Propencil ESU Pencil intended for single-use or reusable applications?

The Propencil ESU Pencil is explicitly designed for single-use only. This ensures sterility and reduces the risk of cross-contamination between patients, aligning with best practices for surgical instruments in controlled environments. Reuse is not recommended or supported by the manufacturer.

How is the Propencil ESU Pencil supplied, and what does ‘sterile’ mean in this context?

The Propencil ESU Pencil is supplied sterile and packaged for immediate surgical use. ‘Sterile’ means it has undergone validated processes (e.g., gamma irradiation or ethylene oxide sterilization) to eliminate microorganisms, ensuring it meets regulatory standards for unopened, uncontaminated surgical tools. The packaging remains intact until first use to maintain sterility.

What regulatory pathway does the Propencil ESU Pencil follow, and what does ‘SESE’ mean?

The Propencil ESU Pencil follows the FDA 510(k) clearance pathway, specifically under the Substantially Equivalent (SESE) determination. ‘SESE’ indicates the device is deemed equivalent to a legally marketed predicate device in terms of technology and performance, allowing it to enter the market without requiring demonstration of substantial equivalence to an unapproved device. The clearance number is K092732.

Are there different models or sizes available for the Propencil ESU Pencil?

The provided data does not specify multiple models or sizes for the Propencil ESU Pencil. It is classified under product code GEI (General Electrosurgery Instruments), which typically includes standard designs for general use. For exact specifications (e.g., tip configurations, cable lengths), consult the manufacturer’s technical documentation or contact Bio Protech Inc. directly.

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: PROPENCIL ESU PENCIL by BIO PROTECH, INC. | FDA 510(k) Summary, PROPENCIL ESU PENCIL (K092732) — FDA 510 (k) | Innolitics, PDF PROPENCIL ESU PENCIL 510 (k) K092732 - FDA.report, PDF K092732 PROPENCIL ESU PENCIL - 510kdatabase.net, PROPENCIL ESU PENCIL 510 (k) K092732 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bio Protech Inc.
FDA Applicant
Bio Protech, Inc.

Sources (1)

  • FDA 510(k) K092732 24 fields · synced Oct 1, 2026