BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768— 510(k) K860687

Name: FDA 510(k) clearance K860687
Creator: U.S. Food and Drug Administration
Published: 1986-03-24

Substantially Equivalent

Birtcher Corp.

FDA 510(k) clearance K860687 for BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768, Substantially Equivalent on 1986-03-24. Applicant: Birtcher Corp.. Device class: 2.

Clearance details

Applicant: Birtcher Corp.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1986-02-25
Decision date: 1986-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Monte, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEI

view all

K254185 — Potenza Prime2026-09-11
K262364 — Ellian Enigma RF Device2026-09-02
K253859 — Scarlet Pro (Scarlet Pro)2026-08-27
K252535 — Inno-Switch Laparoscopic Instruments2026-08-25
K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

More clearances from Birtcher Corp.

view all

K881328 — MODEL 375 ECG1988-05-18
K860718 — ELECTROSURGERY PENCIL, MODEL 7671986-03-24
K854814 — SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 331986-01-13
K854864 — BI-POLAR FORCEPS1985-12-24
K850668 — ELECTROSURGICAL UNIT 7741985-05-20

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.