Cleared Special

K181974 - MyoSure XL Tissue Removal Device for Fluent

K181974 is an FDA 510(k) clearance for MyoSure XL Tissue Removal Device for Fluent, 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 30-day FDA review.

K181974 · Hologic, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
30d
Days
Class 2
Risk

K181974 is an FDA 510(k) clearance for the MyoSure XL Tissue Removal Device for Fluent. 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 August 23, 2018 after a review of 30 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K181974

510(k) Number K181974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2018
Decision Date August 23, 2018
Days to Decision 30 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
131d faster than avg
Panel avg: 161d · This submission: 30d
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 167
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K181974.
Polygon Resection Device
K182675 · Polygon Medical, Inc. · Jan 2019
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
K182006 · Hologic, Inc. · Dec 2018
TruClear Elite Hysteroscope
K180496 · Covidien · Aug 2018
Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole
K180752 · Corinth Medtech, Inc. · Jul 2018
HSW Resection Instruments
K173070 · Henke-Sass, Wolf GmbH · Jun 2018
MyoSure MANUAL Tissue Removal Device
K173901 · Hologic, Inc. · May 2018
K181974 · MyoSure XL Tissue Removal Device for Fluent
Download PDF FDA Summary Hologic, Inc.