Conveen(R) Self-Sealing Urisheath Male External Catheter
FDA 510(k) K946243 · Coloplast A/S
510(k) numberK946243
Submission
- Device name
- Conveen(R) Self-Sealing Urisheath Male External Catheter
- Applicant
- Coloplast A/S
Marietta, GA, US - Received
- December 22, 1994
- Decision date
- February 13, 1995
- 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 |
|---|---|---|---|
| K970465 | Bouser's UrinalEXJ · Traditional | General Polymers | 12/18/1997SE |
| 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 |
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Questions and answers
When was Conveen(R) Self-Sealing Urisheath Male External Catheter cleared by the FDA?
Conveen(R) Self-Sealing Urisheath Male External Catheter (K946243) received a 510(k) decision of Substantially Equivalent on February 13, 1995, 53 days after the submission was received.
What is the product code of K946243?
The FDA product code is EXJ – Device, Incontinence, Urosheath Type, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.