Cleared Special

K100559 - MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

K100559 is an FDA 510(k) clearance for MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM, manufactured by Interlace Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Special 510(k) pathway after a 29-day FDA review.

K100559 · Interlace Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
29d
Days
Class 2
Risk

K100559 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 Interlace Medical, Inc. (Farmingham, US). The FDA issued a Cleared decision on March 30, 2010 after a review of 29 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 - K100559

510(k) Number K100559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2010
Decision Date March 30, 2010
Days to Decision 29 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
132d faster than avg
Panel avg: 161d · This submission: 29d
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 K100559.
TRUCLEAR INCISOR PLUS BLADE 2.9
K103389 · Smith & Nephew, Inc. · Mar 2011
MYOSURE ROD LENS SCOPE SEALS
K102686 · Interlace Medical, Inc. · Oct 2010
FEMEYE TWO
K093218 · Fem Suite, LLC · May 2010
ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
K092421 · Gimmi GmbH · Feb 2010
OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK
K091838 · Obp Medical · Dec 2009
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
K091100 · Interlace Medical, Inc. · Oct 2009
K100559 · MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Download PDF FDA Summary Interlace Medical, In…