Submission Details
| 510(k) Number | K881213 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 21, 1988 |
| Decision Date | July 28, 1988 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
K881213 - GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER
(FDA 510(k) Clearance)
Jul 1988
Decision
129d
Days
Class 2
Risk
K881213 is an FDA 510(k) clearance for the GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER. This device is classified as a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX).
Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on July 28, 1988, 129 days after receiving the submission on March 21, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
Device Classification
| Product Code | KNX — Collector, Urine, (and Accessories) For Indwelling Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5250 |
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