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# Safe Medical Design Urinary Catheter Cleared
- URL: https://www.fdaweb.com/safe-medical-design-urinary-catheter-cleared/
- Published: 2019-03-04T12:00:00.000Z
- Updated: 2026-09-15T01:09:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143376

FDA has cleared a Safe Medical Design 510(k) for the Signal Catheter, a urinary catheter that is designed to reduce urethral trauma caused by premature balloon inflation during placement. The company says that there are 30 million urethral catheters annually used in the U.S., with up to 500,000 incidences of urethral trauma reported during catheter insertion. “The accidental inflation of a traditional catheter in the urethra can cause painful, long-lasting and costly damage to patients,” it says. Data were presented at the 2018 American Urological Association annual meeting demonstrating that accidental inflation of the catheter’s balloon within the urethra using the Signal Catheter results in significantly lower intraurethral balloon pressures when compared to the market leading urethral catheter, the company adds.