Cleared Special

K102686 - MYOSURE ROD LENS SCOPE SEALS

K102686 is an FDA 510(k) clearance for MYOSURE ROD LENS SCOPE SEALS, 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 28-day FDA review.

K102686 · Interlace Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
28d
Days
Class 2
Risk

K102686 is an FDA 510(k) clearance for the MYOSURE ROD LENS SCOPE SEALS. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Interlace Medical, Inc. (Framingham, US). The FDA issued a Cleared decision on October 15, 2010 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 - K102686

510(k) Number K102686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2010
Decision Date October 15, 2010
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 167
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K102686.
TRUCLEAR OPERATIVE HYSTEROSCOPE
K112134 · Smith & Nephew, Inc. · Nov 2011
TRUCLEAR MORCELLATOR SYSTEM
K110038 · Smith & Nephew, Inc. · Mar 2011
TRUCLEAR INCISOR PLUS BLADE 2.9
K103389 · Smith & Nephew, Inc. · Mar 2011
FEMEYE TWO
K093218 · Fem Suite, LLC · May 2010
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
K100559 · Interlace Medical, Inc. · Mar 2010
ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
K092421 · Gimmi GmbH · Feb 2010
K102686 · MYOSURE ROD LENS SCOPE SEALS
Download PDF FDA Summary Interlace Medical, In…