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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K182006

Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths · Hologic, Inc. · decided 2018-12-06 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Omni Hysteroscopy Light Set60-250-2Hologic, Inc.HIH25420045510347
6mm Operative Sheath60-203Hologic, Inc.HIH15420045510289
5.5mm Operative Sheath60-202Hologic, Inc.HIH15420045510272
Omni Hysteroscopy Standard Set60-250-1Hologic, Inc.HIH25420045510354
3.7mm Diagnostic Sheath60-201Hologic, Inc.HIH15420045510265
Omni Hysteroscope60-200Hologic, Inc.HIH15420045510258