Submission Details
| 510(k) Number | K022112 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 28, 2002 |
| Decision Date | April 03, 2003 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
Cleared
Traditional
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
Apr 2003
Decision
279d
Days
Class 2
Risk
About This 510(k) Submission
K022112 is an FDA 510(k) clearance for the FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Fortune Medical Instrument Corp. (Taipei Hsien, TW). The FDA issued a Cleared decision on April 3, 2003, 279 days after receiving the submission on June 28, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
Device Classification
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |
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