Submission Details
| 510(k) Number | K910197 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 1991 |
| Decision Date | August 09, 1991 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS
Aug 1991
Decision
205d
Days
Class 2
Risk
About This 510(k) Submission
K910197 is an FDA 510(k) clearance for the HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS, a Catheter, Coude (Class II — Special Controls, product code EZC), submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on August 9, 1991, 205 days after receiving the submission on January 16, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
Device Classification
| Product Code | EZC — Catheter, Coude |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |
Manufacturer
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