Comfort Cath Choice Male External Catheter
FDA 510(k) K970966 · Sierra Laboratories, Inc.
510(k) numberK970966
Submission
- Device name
- Comfort Cath Choice Male External Catheter
- Applicant
- Sierra Laboratories, Inc.
Tucson, AZ, US - Received
- March 17, 1997
- Decision date
- April 22, 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 |
|---|---|---|---|
| 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 |
| 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 |
More from Convatec, A Division of E.R. Squibb & Sons
| 510(k) | Device | Decision |
|---|---|---|
| K962413 | Comfort Cath Special Self Adhering Male External CatheterEXJ · Traditional | 07/15/1996SE |
| K962384 | Comfort Sheath Reusable Male External CatheterEXJ · Traditional | 07/15/1996SE |
| K934266 | Comfort Cath Self Adhering Male External CatheterEXJ · Traditional | 04/19/1994SE |
| K934052 | Alpine Reusable Leg BagsFAQ · Traditional | 01/07/1994SE |
| K931156 | Cone CathEXJ · Traditional | 07/01/1993SE |
| K901000 | Uro Tex UrinalsEYZ · Traditional | 03/26/1990SE |
| K883057 | Comfort Cath Male External CatheterEYT · Traditional | 08/02/1988SE |
| K873039 | Model 820 Top=TrakBYN · Traditional | 02/11/1988SE |
| K832450 | Uro-Tex Male External CatheterKNX · Traditional | 10/14/1983SE |
| K811887 | Skin Staple ExtractorKBC · Traditional | 07/27/1981SE |
Questions and answers
When was Comfort Cath Choice Male External Catheter cleared by the FDA?
Comfort Cath Choice Male External Catheter (K970966) received a 510(k) decision of Substantially Equivalent on April 22, 1997, 36 days after the submission was received.
What is the product code of K970966?
The FDA product code is EXJ – Device, Incontinence, Urosheath Type, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.