REPROCESSED STONE RETRIEVAL BASKETS— 510(k) K012581

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K012581 for REPROCESSED STONE RETRIEVAL BASKETS, Substantially Equivalent on 2002-02-14. Applicant: Sterilmed, Inc..

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 2001-08-09
Decision date: 2002-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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Adverse events under product code FFL

product code FFL

Death: 2
Injury: 270
Malfunction: 2,711
Other: 2
Total: 2,985

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.