Clearance Summary
HI-TEC CO2 INSUFFLATOR TYPE 1300 received FDA 510(k) clearance under submission number K955477, sponsored by Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1997-08-06.
- Submission: K955477
- Applicant / Sponsor: Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1997-08-06
Classification & Regulation
This clearance is catalogued under FDA product code HIF and 21 CFR 884.1730, within the Obstetrics/Gynecology review panel as a Class II device.