GASTROSCAN— 510(k) K905154

Name: FDA 510(k) clearance K905154
Creator: U.S. Food and Drug Administration
Published: 1991-06-19

Substantially Equivalent

Medics Instrument Corp.

FDA 510(k) clearance K905154 for GASTROSCAN, Substantially Equivalent on 1991-06-19. Applicant: Medics Instrument Corp.. Device class: 2.

Clearance details

Applicant: Medics Instrument Corp.
Product code: Code FFX
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 1990-11-15
Decision date: 1991-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solothurn, Switzerland, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code FFX

view all

K252605 — mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)2025-12-05
K240007 — Solar Compact (G4-1)2024-05-06
K231861 — EndoflipTM 300 System2023-07-21
K223705 — EndoflipTM 3002023-04-14
K222000 — Transit-Pellets2023-01-18

More clearances from Medics Instrument Corp.

view all

K903646 — GASTROGRAPH1990-11-05
K821333 — ATRIAL J TEMPORARY PACING ELECTRODESS1982-06-02
K812517 — CARDIAC PACING ELECTRODES1981-10-13

Adverse events under product code FFX

product code FFX

Other: 1
Total: 1

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.