Urihesive Strip
FDA 510(k) K915616 · Convatec, A Division of E.R. Squibb & Sons
510(k) numberK915616
Submission
- Device name
- Urihesive Strip
- Applicant
- Convatec, A Division of E.R. Squibb & Sons
Princeton, NJ, US - Received
- December 16, 1991
- Decision date
- January 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code EXI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K915246 | Conveen(R) Urisheath and Uriliner(Male Exter Cath)EXI · Traditional | Coloplast A/S | 02/05/1992SE |
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Questions and answers
When was Urihesive Strip cleared by the FDA?
Urihesive Strip (K915616) received a 510(k) decision of Substantially Equivalent on January 23, 1992, 38 days after the submission was received.
What is the product code of K915616?
The FDA product code is EXI – Device, Paste-On For Incontinence, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.