Submission Details
| 510(k) Number | K890310 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 23, 1989 |
| Decision Date | November 30, 1989 |
| Days to Decision | 311 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
STERILE FOLEY CATHETER
Nov 1989
Decision
311d
Days
Class 2
Risk
About This 510(k) Submission
K890310 is an FDA 510(k) clearance for the STERILE FOLEY CATHETER, a Catheter, Upper Urinary Tract (Class II — Special Controls, product code EYC), submitted by Kosan Far East Ent. , Ltd. (Hong Kong, TW). The FDA issued a Cleared decision on November 30, 1989, 311 days after receiving the submission on January 23, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
Device Classification
| Product Code | EYC — Catheter, Upper Urinary Tract |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |
Manufacturer
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