K940661 is an FDA 510(k) clearance for the STIEGMANN-GOFF ENDOSCOPIC LIGATOR. This device is classified as a Ligator, Esophageal (Class II - Special Controls, product code MND).
Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on November 28, 1994, 286 days after receiving the submission on February 15, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K940661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 1994 |
| Decision Date | November 28, 1994 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| 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 |