Cleared Traditional

Omni Hysteroscope, Omni Lok cervical seal

K191281 · Hologic, Inc. · Obstetrics & Gynecology
Aug 2019
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K191281 is an FDA 510(k) clearance for the Omni Hysteroscope, Omni Lok cervical seal, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Hologic, Inc. (Marlborough, US). The FDA issued a Cleared decision on August 29, 2019, 108 days after receiving the submission on May 13, 2019. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K191281 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2019
Decision Date August 29, 2019
Days to Decision 108 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIH — Hysteroscope (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1690

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