K943989 is an FDA 510(k) clearance for the LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT. This device is classified as a Recorder, Pressure, Intrauterine (Class II - Special Controls, product code HFO).
Submitted by Gabris Surgical Corp. (Virginia Beach, US). The FDA issued a Cleared decision on September 12, 1994, 27 days after receiving the submission on August 16, 1994.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2700.
| 510(k) Number | K943989 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 1994 |
| Decision Date | September 12, 1994 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HFO — Recorder, Pressure, Intrauterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2700 |