Panels › Gastroenterology, Urology › Product code JCW · Class 3
Prosthesis, Penis, Inflatable
Regulation 876.3350
0510(k)s in 12 months (0 all time)
0recalls in 12 months (19 all time)
0recalls that name a 510(k)
Top companies in JCW
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 0 | 10 |
| American Medical Systems | 0 | 9 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2025 | Boston Scientific Corporation LGX Preconnect with TENACIO Pump with InhibiZone;
UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) Open, Classified |
JCW | None listed |
| Oct 10, 2025 | Boston Scientific Corporation CXR Preconnect with TENACIO Pump with InhibiZone;
UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) Open, Classified |
JCW | None listed |
| Oct 10, 2025 | Boston Scientific Corporation CX Preconnect with TENACIO Pump with InhibiZone;
UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 7 Open, Classified |
JCW | None listed |
| Oct 10, 2025 | Boston Scientific Corporation LGX Preconnect with TENACIO Pump without InhibiZone;
UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP); Open, Classified |
JCW | None listed |
| Oct 10, 2025 | Boston Scientific Corporation CX Preconnect with TENACIO Pump without InhibiZone;
UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP); Open, Classified |
JCW | None listed |
| Oct 10, 2025 | Boston Scientific Corporation TENACIO Pump without InhibiZone;
UPN: 72404420; Open, Classified |
JCW | None listed |
| Oct 10, 2025 | Boston Scientific Corporation TENACIO Pump with InhibiZone;
UPN: 72404429; Open, Classified |
JCW | None listed |
| Mar 26, 2021 | Boston Scientific Corporation The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reser Terminated |
JCW | None listed |
| Nov 6, 2020 | Boston Scientific Corporation AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis Open, Classified |
JCW | None listed |
| Jan 28, 2020 | Boston Scientific Corporation AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). Terminated |
JCW | None listed |
| Nov 13, 2014 | American Medical Systems, Inc. AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850.
Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (F Terminated |
JCW | None listed |
| Sep 20, 2008 | American Medical Systems AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Lot 551668001. Expiration Date 2010-Jun-20, Manufacture Date 2008 Jun 20. Terminated |
JCW | None listed |
| May 9, 2007 | American Medical Systems AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm, product number 72404251. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders. Terminated |
JCW | None listed |
| May 9, 2007 | American Medical Systems AMS 700 CX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm product number 72404231. Penoscrotal Approach - with InhibiZone, 1 Pump, 2 Cylinders. Terminated |
JCW | None listed |
| May 9, 2007 | American Medical Systems AMS 700 CX Preconnected penile Prosthesis with InhibiZone, product length 18 cm, product number 72402987. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Pump Terminated |
JCW | None listed |
| May 9, 2007 | American Medical Systems AMS 700 CX MS Pump IZ Preconnected penile Prosthesis, product length 18 cm, product number 72404232. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders. Terminated |
JCW | None listed |
| May 9, 2007 | American Medical Systems AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Terminated |
JCW | None listed |
| Apr 29, 2004 | American Medical Systems AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451 Terminated |
JCW | None listed |
| Apr 29, 2004 | American Medical Systems AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450 Terminated |
JCW | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.