510(k) K770789 ยท KNX Collector, Urine, (And Accessories) For Indwelling Catheter
URI-DRAIN COMBO KIT FOR MALE INCONTINENC
| Applicant | Chesebrough-Pond'S U.S.A. Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 18, 1977 |
| Received | May 3, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K770789
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2011 | Covidien LP URI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin Protective Wipe
Product ID: 8884732000
Intended use: Collector urine from male patients (and accessories) for indwelling Terminated |
KNX | None listed |
| May 27, 2011 | Covidien LP URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe
Product ID: 8884732500
Intended use: Collector urine from male patients (and accessories) for indwelli Terminated |
KNX | None listed |
| May 27, 2011 | Covidien LP URI-DRAIN Male Urinary Control Device - Large
Product ID: 8884732598 (sold in Canada only)
Intended use:Collector urine from male patients (and accessories) for indwelling catheter Terminated |
KNX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.