Cleared Traditional

K111014 - LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES

K111014 is an FDA 510(k) clearance for LSI SOLUTIONS FORNISEE SYSTEM UTERINE M..., manufactured by Lsi Solutions, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEW cleared through the Traditional 510(k) pathway after a 459-day FDA review.

K111014 · Lsi Solutions, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
459d
Days
Class 2
Risk

K111014 is an FDA 510(k) clearance for the LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES. Classified as Culdoscope (and Accessories) (product code HEW), Class II - Special Controls.

Submitted by Lsi Solutions, Inc. (Victor, US). The FDA issued a Cleared decision on July 13, 2012 after a review of 459 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1640 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Lsi Solutions, Inc. devices

FDA 510(k) Submission Details - K111014

510(k) Number K111014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2011
Decision Date July 13, 2012
Days to Decision 459 days
Submission Type Traditional
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
298d slower than avg
Panel avg: 161d · This submission: 459d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEW Device Classification - Class 2, Special Controls

Product Code HEW Culdoscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1640
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 - HEW Culdoscope (and Accessories)

All 17
Devices cleared under the same product code (HEW) and FDA review panel - the closest regulatory comparables to K111014.
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SINGHMED ROOLIP MANIPULATOR
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MANIPUSEAL
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MCCARTNEY ACCESS TUBE
K051594 · Gynetech Pty. , Ltd. · Sep 2005