K093329 is an FDA 510(k) clearance for the SCOPE INTRODUCER MODEL 7400. This device is classified as a Endoscope Channel Accessory (Class II — Special Controls, product code ODC).
Submitted by N.M. Beale Co., Inc. (Ayer, US). The FDA issued a Cleared decision on February 16, 2010, 113 days after receiving the submission on October 26, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Give The Endoscope Channel Additional Or Improved Functionality..
| 510(k) Number | K093329 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 26, 2009 |
| Decision Date | February 16, 2010 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODC — Endoscope Channel Accessory |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Give The Endoscope Channel Additional Or Improved Functionality. |