MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER— 510(k) K012374

Substantially Equivalent

Astra Tech, Inc.

FDA 510(k) clearance K012374 for MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER, Substantially Equivalent on 2001-08-23. Applicant: Astra Tech, Inc..

Clearance details

Applicant: Astra Tech, Inc.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 2001-07-26
Decision date: 2001-08-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Northborough, MA, US

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Adverse events under product code GBM

product code GBM

Injury: 397
Malfunction: 1,404
Total: 1,801

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.