Product code EXJ— Gastroenterology, Urology
BOUSER'S URINAL
- Classification name
- Device, Incontinence, Urosheath Type, Sterile
- Device class
- Class 1
- Regulation
- 21 CFR 876.5250
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 22
- First cleared
- Most recent
Market context for product code EXJ
FDA has cleared devices under product code EXJ between 1977 and 1997, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1985
- 1977
Top applicants under product code EXJ
Recent clearances under product code EXJ
- K970465 — BOUSER'S URINAL
- K972100 — VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)
- K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER
- K963265 — PROSYS SAMEC LA
- K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER
- K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
- K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
- K952082 — ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER
- K945628 — CLEAR ADVANTAGE II
- K951530 — PROSYS URIHESIVE SYSTEM LA
- K950690 — PROSYS URIHESICE SYSTEM NL
- K942941 — CONQUEST MALE CONTINENCE SYSTEM
- K946243 — CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER
- K940269 — HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER
- K934266 — COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
- K931156 — CONE CATH
- K923136 — MALE EXTERNAL CATHETER
- K924407 — CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
- K913524 — SILICONE MALE EXTERNAL CATHETER
- K903715 — CONDOM SEAL
- K851682 — SAFESEAL REUSABLE URINAL SYSTEM
- K772144 — CATHETER, DISP., EXTERNAL, MALE
Data sourced from openFDA. This site is unofficial and independent of the FDA.