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OBS Disposable Electrosurgical Pencils, Models: OBS-DB, OBS-DR, OBS-DF

by Jiangmen City Xinhui Baisheng Medical Equipment CO

510(k) K092634

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 NumberK092634 Date1 Dec 2009ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

OBS Disposable Electrosurgical Pencils, Models: OBS-DB, OBS-DR, OBS-DF are electrosurgical devices used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery. They are designed for use with a 510k-cleared electrosurgical generator.

These pencils are supplied as single-use, sterile devices. They are intended for use in general and plastic surgery settings. The device has received FDA 510(k) clearance under product code GEI, with K number K092634, and was determined to be substantially equivalent to a predicate device.

Other devices from Jiangmen City Xinhui Baisheng Medical Equipment CO

Questions

AI-generated answers, 6 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 are OBS Disposable Electrosurgical Pencils used for?

    OBS Disposable Electrosurgical Pencils models OBS-DB, OBS-DR, OBS-DF are used for cutting and coagulation to remove tissue and control bleeding during electrosurgical surgery by delivering high frequency current, intended for general and plastic surgery settings.

  • How are OBS Disposable Electrosurgical Pencils supplied and are they reusable?

    OBS Disposable Electrosurgical Pencils models OBS-DB, OBS-DR, OBS-DF are supplied as sterile, single-use devices and are not intended for reuse; they must be discarded after one procedure to ensure patient safety and device performance.

  • What regulatory clearance do OBS Disposable Electrosurgical Pencils have?

    OBS Disposable Electrosurgical Pencils models OBS-DB, OBS-DR, OBS-DF have received FDA 510(k) clearance under K number K092634 and product code GEI, determined to be substantially equivalent to a predicate device.