Conquest Male Continence System
FDA 510(k) K942941 · Convatec, A Bristol-Myers Squibb Co.
510(k) numberK942941
Submission
- Device name
- Conquest Male Continence System
- Applicant
- Convatec, A Bristol-Myers Squibb Co.
Princeton, NJ, US - Received
- June 22, 1994
- Decision date
- March 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
More from Convatec, A Division of E.R. Squibb & Sons
| 510(k) | Device | Decision |
|---|---|---|
| K032734 | Convatec Fecal Management SystemKNT · Traditional | 04/08/2004SE |
| K990368 | Duoderm Hydroactive Gel Wound DressingMGQ · Traditional | 03/26/1999SE |
| K982116 | Aquacel Hydrofiber Wound DressingKMF · Traditional | 09/08/1998SE |
| K973806 | Duoderm Hydroactive GelMGQ · Traditional | 12/29/1997SN |
| K973807 | Duoderm Hydroactive PasteFRO · Traditional | 12/23/1997SN |
| K973717 | Combiderm AcdFRO · Traditional | 12/17/1997SN |
| K973716 | Duoderm Extra Thin CGF DressingFRO · Traditional | 12/17/1997SN |
| K954918 | Combiderm AcdKMF · Traditional | 12/26/1995SE |
| K940895 | EpiviewMGP · Traditional | 11/22/1994SN |
Questions and answers
When was Conquest Male Continence System cleared by the FDA?
Conquest Male Continence System (K942941) received a 510(k) decision of Substantially Equivalent on March 17, 1995, 268 days after the submission was received.
What is the product code of K942941?
The FDA product code is EXJ – Device, Incontinence, Urosheath Type, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.