Conveen(R) Urisheath and Uriliner(Male Exter Cath)
FDA 510(k) K915246 · Coloplast A/S
510(k) numberK915246
Submission
- Device name
- Conveen(R) Urisheath and Uriliner(Male Exter Cath)
- Applicant
- Coloplast A/S
Fort Woth, TX, US - Received
- November 15, 1991
- Decision date
- February 5, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EXI – Device, Paste-On For Incontinence, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K971499 | Female External Urinary Collection PouchEXI · Traditional | Mediquest, Inc. | 08/28/1997SE |
| K970443 | Hollister Retracted Penis PouchEXI · Traditional | Hollister, Inc. | 02/25/1997SE |
| K963950 | Bioderm Eid Male External Incontinence DeviceEXI · Traditional | Bioderm, Inc. | 01/10/1997SE |
| K931277 | Hollister Premium Urine CollectorEXI · Traditional | Hollister, Inc. | 06/23/1993SE |
| K924755 | Convatec Little Ones Pediatric Urine CollectionEXI · Traditional | Convatec, A Division of E.R. Squibb & Sons | 06/22/1993SE |
| K915616 | Urihesive StripEXI · Traditional | Convatec, A Division of E.R. Squibb & Sons | 01/23/1992SE |
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Questions and answers
When was Conveen(R) Urisheath and Uriliner(Male Exter Cath) cleared by the FDA?
Conveen(R) Urisheath and Uriliner(Male Exter Cath) (K915246) received a 510(k) decision of Substantially Equivalent on February 5, 1992, 82 days after the submission was received.
What is the product code of K915246?
The FDA product code is EXI – Device, Paste-On For Incontinence, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.