DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE— 510(k) K901428

Substantially Equivalent

Telemed Systems, Inc.

FDA 510(k) clearance K901428 for DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE, Substantially Equivalent on 1990-06-18. Applicant: Telemed Systems, Inc..

Clearance details

Applicant: Telemed Systems, Inc.
Product code: Code FDI
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-26
Decision date: 1990-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, MA, US

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Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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.