Bouser's Urinal
FDA 510(k) K970465 · General Polymers
510(k) numberK970465
Submission
- Device name
- Bouser's Urinal
- Applicant
- General Polymers
Great Neck, NY, US - Received
- February 7, 1997
- Decision date
- December 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EXJ – Device, Incontinence, Urosheath Type, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972100 | Vented External Male Urinary Catheter(Vented Cath 5000)EXJ · Traditional | Advanced Care Medical Products | 07/31/1997SE |
| K970966 | Comfort Cath Choice Male External CatheterEXJ · Traditional | Sierra Laboratories, Inc. | 04/22/1997SE |
| K963265 | Prosys Samec laEXJ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 10/25/1996SE |
| K962900 | Self Retaining Male External Urinary CatheterEXJ · Traditional | Hollister, Inc. | 09/16/1996SE |
| K962413 | Comfort Cath Special Self Adhering Male External CatheterEXJ · Traditional | Sierra Laboratories, Inc. | 07/15/1996SE |
| K962384 | Comfort Sheath Reusable Male External CatheterEXJ · Traditional | Sierra Laboratories, Inc. | 07/15/1996SE |
| K952082 | Rochester Medical Corporation Silicone Male External CatheterEXJ · Traditional | Rochester Medical Corp. | 07/18/1995SE |
| K945628 | Clear Advantage IIEXJ · Traditional | Mentor Corp. | 07/06/1995SE |
| K951530 | Prosys Urihesive System laEXJ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 05/12/1995SE |
| K950690 | Prosys Urihesice System NLEXJ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 03/23/1995SE |
Questions and answers
When was Bouser's Urinal cleared by the FDA?
Bouser's Urinal (K970465) received a 510(k) decision of Substantially Equivalent on December 18, 1997, 314 days after the submission was received.
What is the product code of K970465?
The FDA product code is EXJ – Device, Incontinence, Urosheath Type, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.