Self Retaining Male External Urinary Catheter
FDA 510(k) K962900 · Hollister, Inc.
510(k) numberK962900
Submission
- Device name
- Self Retaining Male External Urinary Catheter
- Applicant
- Hollister, Inc.
Libertyville, IL, US - Received
- July 25, 1996
- Decision date
- September 16, 1996
- 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 |
| 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 |
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| K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…EZD · Traditional | 05/03/2024SE |
| K220667 | Sleeved ICEZD · Traditional | 12/08/2022SE |
| K213575 | Female IC (Not Finalized)EZD · Traditional | 09/13/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | 01/27/2022SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | 12/13/2019SE |
| K191633 | Infyna ChicGBM · Special | 07/19/2019SE |
| K183253 | ValPro 2 Plus, VaPro 2 Plus PocketGBM · Special | 12/18/2018SE |
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Questions and answers
When was Self Retaining Male External Urinary Catheter cleared by the FDA?
Self Retaining Male External Urinary Catheter (K962900) received a 510(k) decision of Substantially Equivalent on September 16, 1996, 53 days after the submission was received.
What is the product code of K962900?
The FDA product code is EXJ – Device, Incontinence, Urosheath Type, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.