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Model E2510 Surgiswitch

by Valleylab, Inc.

510(k) K791638

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 NumberK791638 Date12 Sep 1979ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

The Model E2510 Surgiswitch is an electrosurgical device designed for cutting and coagulation procedures. It falls under the classification of electrosurgical cutting and coagulation accessories, intended for use in general and plastic surgery applications.

This device is supplied as a reusable electrosurgical pencil with a stainless steel electrode, featuring either button or rocker switch controls. It was granted FDA 510(k) clearance under K791638 with a decision of Substantially Equivalent (SESE) in 1979, classified under regulation 878.4400. The device is intended for use in controlled surgical environments and requires proper training for operation.

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