Cleared Special

K122563 - MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL

K122563 is an FDA 510(k) clearance for MYOSURE XL ROD LENS 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 28-day FDA review.

K122563 · Hologic, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
28d
Days
Class 2
Risk

K122563 is an FDA 510(k) clearance for the MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL. 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 September 19, 2012 after a review of 28 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 - K122563

510(k) Number K122563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2012
Decision Date September 19, 2012
Days to Decision 28 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
133d faster than avg
Panel avg: 161d · This submission: 28d
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 168
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K122563.
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
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
K122498 · Hologic, Inc. · Sep 2012
MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
K121868 · Hologic, Inc. · Jul 2012
MYOSURE CONTROL UNIT
K120593 · Hologic, Inc. · Mar 2012
K122563 · MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
Download PDF FDA Summary Hologic, Inc.