Cleared Special

K182006 - Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths

K182006 is an FDA 510(k) clearance for Omni Hysteroscope, manufactured by Hologic, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Special 510(k) pathway after a 132-day FDA review.

K182006 · Hologic, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
132d
Days
Class 2
Risk

K182006 is an FDA 510(k) clearance for the Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Cleared decision on December 6, 2018 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K182006

510(k) Number K182006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2018
Decision Date December 06, 2018
Days to Decision 132 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 161d · This submission: 132d
Pathway characteristics
Modification to existing cleared device.

HIH Device Classification - Class 2, Special Controls

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 174
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K182006.
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Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole
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K182006 · Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
Download PDF FDA Summary Hologic, Inc.