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Birt-A-Switch DSP Push Button, Model No. 768

by Birtcher Corp. 510(k)

Active United States

510(k) K860687

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK860687 Date24 Mar 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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 Birt-A-Switch DSP Push Button, Model No. 768, is a disposable plastic surgical push-button device designed for use in orthopedic and plastic surgery procedures. It serves as a mechanical switch to facilitate the activation or deactivation of surgical instruments or systems during procedures.

This device is supplied as a single-use item and is intended for use in sterile surgical environments. It is classified under product code GEI (General and Plastic Surgery Devices) and holds an FDA 510(k) clearance (K860687) for substantial equivalence. No additional regulatory markings or sterility assurances are specified beyond its classification and clearance status.

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