K881507 is an FDA 510(k) clearance for the ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES. This device is classified as a Laser, Surgical, Gynecologic (Class II - Special Controls, product code HHR).
Submitted by Hgm Medical Laser Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 27, 1989, 381 days after receiving the submission on April 11, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4550.
| 510(k) Number | K881507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 1988 |
| Decision Date | April 27, 1989 |
| Days to Decision | 381 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HHR — Laser, Surgical, Gynecologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4550 |