K033245 is an FDA 510(k) clearance for the BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U. This device is classified as a Ligator, Esophageal (Class II - Special Controls, product code MND).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on November 6, 2003, 30 days after receiving the submission on October 7, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K033245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2003 |
| Decision Date | November 06, 2003 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MND — Ligator, Esophageal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4400 |