BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE— 510(k) K897005

Substantially Equivalent

Helix Medical, Inc.

FDA 510(k) clearance K897005 for BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE, Substantially Equivalent on 1990-03-16. Applicant: Helix Medical, Inc..

Clearance details

Applicant: Helix Medical, Inc.
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 1989-12-18
Decision date: 1990-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbera, CA, US

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Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

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.