Cleared Traditional

K142029 - MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SY...

K142029 is the FDA 510(k) clearance for MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SY... by Hologic, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K142029 · Hologic, Inc. · Obstetrics & Gynecology device
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Nov 2014
Decision
124d
Days
Class 2
Risk

K142029 is an FDA 510(k) clearance for the MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM. 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 November 26, 2014 after a review of 124 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hologic, Inc. devices

Submission Details

510(k) Number K142029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2014
Decision Date November 26, 2014
Days to Decision 124 days
Submission Type Traditional
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
36d faster than avg
Panel avg: 160d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 96
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K142029.
Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
K161763 · Smith & Nephew, Inc. · Nov 2016
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K152723 · Hologic, Inc. · Nov 2015
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
K152143 · Smith & Nephew, Inc. · Sep 2015
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
K132015 · Smith & Nephew, Inc. · Dec 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
K131581 · Hologic, Inc. · Aug 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
K131736 · Hologic, Inc. · Aug 2013