DeviceClearance

Product code MIB— Ear, Nose, Throat

Pre-Formed Penile Silicone Block

Classification name
Elastomer, Silicone Block
Device class
Class 2
Regulation
21 CFR 874.3620
Advisory panel
Ear, Nose, Throat
Total cleared
45
First cleared
Most recent

Market context for product code MIB

FDA has cleared 45 devices under product code MIB between 1992 and 2024, filed by 24 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 MIB

Adverse events under product code MIB

product code MIB
Injury
146
Total
146

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 MIB

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