UROSPROBE SYSTEM, MODEL 1000— 510(k) K960387

Substantially Equivalent

Uros Corp.

FDA 510(k) clearance K960387 for UROSPROBE SYSTEM, MODEL 1000, Substantially Equivalent on 1996-04-01. Applicant: Uros Corp..

Clearance details

Applicant: Uros Corp.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 1996-01-26
Decision date: 1996-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

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.