ALGINATE FIBER— 510(k) K905040

Substantially Equivalent for Some Indications

Shepherd Medical Corp.

FDA 510(k) clearance K905040 for ALGINATE FIBER, Substantially Equivalent for Some Indications on 1991-08-21. Applicant: Shepherd Medical Corp..

Clearance details

Applicant: Shepherd Medical Corp.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1990-11-06
Decision date: 1991-08-21
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Alexandria, VA, US

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.