K003956 is an FDA 510(k) clearance for the BARD ENDOCINCH SUTURING SYSTEM # 000452. This device is classified as a Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) (Class II - Special Controls, product code ODE).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on January 5, 2001, 15 days after receiving the submission on December 21, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Treat The Symptoms Of Chronic Gastroesophageal Reflux Disease (gerd), Either By Approximating Tissue With Sutures Or Plicating Tissue With An Implant..
| 510(k) Number | K003956 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2000 |
| Decision Date | January 05, 2001 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODE — Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Treat The Symptoms Of Chronic Gastroesophageal Reflux Disease (gerd), Either By Approximating Tissue With Sutures Or Plicating Tissue With An Implant. |