SILICONE ANTIBACTERIAL FOLEY CATHETER— 510(k) K971627

Substantially Equivalent

Rochester Medical Corp.

FDA 510(k) clearance K971627 for SILICONE ANTIBACTERIAL FOLEY CATHETER, Substantially Equivalent on 1998-01-13. Applicant: Rochester Medical Corp..

Clearance details

Applicant: Rochester Medical Corp.
Product code: Code MJC
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-02
Decision date: 1998-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stewartville, MN, US

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Adverse events under product code MJC

product code MJC

Injury: 398
Malfunction: 12,582
Other: 2
Total: 12,982

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.