DeviceClearance

Product code GBM— Gastroenterology, Urology

SpeediCath Compact Set

Classification name
Catheter, Urethral
Device class
Class 2
Regulation
21 CFR 876.5130
Advisory panel
Gastroenterology, Urology
Total cleared
71
First cleared
Most recent

Market context for product code GBM

FDA has cleared 71 devices under product code GBM between 1976 and 2025, filed by 41 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code GBM

Adverse events under product code GBM

product code GBM
Injury
397
Malfunction
1,404
Total
1,801

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code GBM

Data sourced from openFDA. This site is unofficial and independent of the FDA.