Cleared Special

K121868 - MYOSURE LITE TISSUE REMOVAL DEVICE (1 P...

K121868 is the FDA 510(k) clearance for MYOSURE LITE TISSUE REMOVAL DEVICE (1 P... by Hologic, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Special 510(k) pathway after a 23-day FDA review.

K121868 · Hologic, Inc. · Obstetrics & Gynecology device
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Jul 2012
Decision
23d
Days
Class 2
Risk

K121868 is an FDA 510(k) clearance for the MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVI.... 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 July 19, 2012 after a review of 23 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.

View all Hologic, Inc. devices

Submission Details

510(k) Number K121868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2012
Decision Date July 19, 2012
Days to Decision 23 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
137d faster than avg
Panel avg: 160d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 98
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K121868.
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
K131736 · Hologic, Inc. · Aug 2013
MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
K122563 · Hologic, Inc. · Sep 2012
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
K122498 · Hologic, Inc. · Sep 2012
MYOSURE CONTROL UNIT
K120593 · Hologic, Inc. · Mar 2012
TRUCLEAR OPERATIVE HYSTEROSCOPE
K112134 · Smith & Nephew, Inc. · Nov 2011
TRUCLEAR MORCELLATOR SYSTEM
K110038 · Smith & Nephew, Inc. · Mar 2011