ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA— 510(k) K934623

Name: FDA 510(k) clearance K934623
Creator: U.S. Food and Drug Administration
Published: 1993-12-02

Substantially Equivalent

Endomedix

FDA 510(k) clearance K934623 for ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA, Substantially Equivalent on 1993-12-02. Applicant: Endomedix. Device class: 2.

Clearance details

Applicant: Endomedix
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1993-09-27
Decision date: 1993-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K930349 — STONE RETRIEVAL BASKET1993-06-09
K926004 — ENDOSCOPE AND ACCOSSORIES1993-02-10
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Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.