FTOClass IIIImplant
Prosthesis, Testicle
Gastroenterology, Urology · 21 CFR 876.3750
Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95
MDR events2All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Injury1
Other1
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Deflation, cause unknown1
Explanted1
Replace1
Unknown (for use when the device problem is not known)1
Trend for “Deflation, cause unknown”
No history to chart.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.