K914459 is an FDA 510(k) clearance for the AUTOMATIC TUBING CLAMP, a Clamp, Tubing, Blood, Automatic (Class II — Special Controls, product code FIG), submitted by Rocky Mountain Research, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 24, 1992, 261 days after receiving the submission on October 7, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K914459 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 07, 1991 |
| Decision Date | June 24, 1992 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FIG — Clamp, Tubing, Blood, Automatic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |