Submission Details
| 510(k) Number | K852913 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 11, 1985 |
| Decision Date | September 05, 1985 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
K852913 - HGM ENDOCOAGULATOR MODEL 20
(FDA 510(k) Clearance)
Sep 1985
Decision
56d
Days
—
Risk
K852913 is an FDA 510(k) clearance for the HGM ENDOCOAGULATOR MODEL 20, submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 5, 1985, 56 days after receiving the submission on July 11, 1985. This device falls under the Gastroenterology & Urology review panel.
Device Classification
| Product Code | — |
| Device Class | — |