Penile Implant Surgical Accessories
Gastroenterology, Urology · 21 CFR 876.3500
Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing.
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
13 firms currently registered for this product code
Scientific Molding Corporation Ltd. Dba Smc Ltd.
Somerset, WI, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Gynamed Instruments
Sialkot Punjab, PK
Mendell
Lakeville, MN, US
Uramix, Inc.
E Lansdowne, PA, US
Metal Craft Machine & Engineering, Inc.
Elk River, MN, US
Isomedix Operations Inc.
Chester, NY, US
Npa De México S. De R.l. De C.v.
TIJUANA Baja California, MX
Boston Scientific Corporation
Saint Paul, MN, US
Rigicon As
Bakirkoy Istanbul, TR
Boston Scientific Corporation
Marlborough, MA, US
Cardinal Health 200, Llc
Waukegan, IL, US
Isomedix Operations Inc.
CHESTER, NY, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.