LIGHTED FLEXGUIDE (MODIFICATION)— 510(k) K953677

Substantially Equivalent

Scientific Sales Intl., Inc.

FDA 510(k) clearance K953677 for LIGHTED FLEXGUIDE (MODIFICATION), Substantially Equivalent on 1995-08-25. Applicant: Scientific Sales Intl., Inc..

Clearance details

Applicant: Scientific Sales Intl., Inc.
Product code: Code BSR
Advisory panel: Anesthesiology
Date received: 1995-08-07
Decision date: 1995-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

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Adverse events under product code BSR

product code BSR

Death: 2
Other: 1
Total: 3

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.