Cleared Special

K131581 - MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)

K131581 is an FDA 510(k) clearance for MYOSURE TISSUE REMOVAL DEVICE (1 PACK A..., 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 83-day FDA review.

K131581 · Hologic, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
83d
Days
Class 2
Risk

K131581 is an FDA 510(k) clearance for the MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK). 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 22, 2013 after a review of 83 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 - K131581

510(k) Number K131581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2013
Decision Date August 22, 2013
Days to Decision 83 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 161d · This submission: 83d
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 166
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K131581.
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
K142029 · Hologic, Inc. · Nov 2014
U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
K132384 · Endosec Corporation · Jul 2014
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
K132015 · Smith & Nephew, Inc. · Dec 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
K131736 · Hologic, Inc. · Aug 2013
IOGYN ENDOSCOPE
K123330 · Iogyn, Inc. · Mar 2013
ENDOSEE MODEL 8000 U-SCOPE
K123151 · Endosee Corp · Mar 2013
K131581 · MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
Download PDF FDA Summary Hologic, Inc.