INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.— 510(k) K934377

Substantially Equivalent

Interventional Thermodynamics, Inc.

FDA 510(k) clearance K934377 for INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D., Substantially Equivalent on 1994-02-07. Applicant: Interventional Thermodynamics, Inc..

Clearance details

Applicant: Interventional Thermodynamics, Inc.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1993-09-09
Decision date: 1994-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.