Submission Details
| 510(k) Number | K880327 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 26, 1988 |
| Decision Date | February 19, 1988 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
MARLEN ULTRA ILEOSTOMY POUCH-5000
Feb 1988
Decision
24d
Days
Class 1
Risk
About This 510(k) Submission
K880327 is an FDA 510(k) clearance for the MARLEN ULTRA ILEOSTOMY POUCH-5000, a Pouch, Colostomy (Class I — General Controls, product code EZQ), submitted by Marlen Mfg. & Development Co. (Bedford, US). The FDA issued a Cleared decision on February 19, 1988, 24 days after receiving the submission on January 26, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5900.
Device Classification
| Product Code | EZQ — Pouch, Colostomy |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.5900 |
Manufacturer
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