Cleared Traditional

K122820 - VIKY UP

K122820 is an FDA 510(k) clearance for VIKY UP, manufactured by Endocontrol. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K122820 · Endocontrol · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
277d
Days
Class 2
Risk

K122820 is an FDA 510(k) clearance for the VIKY UP. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Endocontrol (La Tronche, FR). The FDA issued a Cleared decision on June 18, 2013 after a review of 277 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K122820

510(k) Number K122820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2012
Decision Date June 18, 2013
Days to Decision 277 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
116d slower than avg
Panel avg: 161d · This submission: 277d
Pathway characteristics
Predicate-based equivalence.

LKF Device Classification - Class 2, Special Controls

Product Code LKF Cannula, Manipulator/injector, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01531504 Completed Interventional Industry-sponsored

New Use of the ViKY Device for Uterus Positioning

Evaluation of Safety and Effectiveness of ViKY Device for Uterine Positioning

30
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Surgical Procedure, Unspecified
Study design Single group
Eligibility Female only · 18 Years+
Principal investigator Arnold ADVINCULA, MD
Sponsor EndoControl (industry)
Started 2011-12-01 → Primary completion 2012-08-01 → Completed 2012-09-01
Primary outcome
Effectiveness
Secondary outcome
surgery characterization
Study completed - no results published. This trial concluded in 2012 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - LKF Cannula, Manipulator/injector, Uterine

All 86
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K122820.
ALLY UPS
K141523 · CooperSurgical, Inc. · Nov 2014
CLEARVIEW TOTAL
K131781 · Clinical Innovations, LLC · May 2014
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
K130758 · Kronner Prototypes, Inc. · Dec 2013
THE ADVANCE CATHETER FOR HSG AND SIS
K123258 · Catheter Research, Inc. · Jan 2013
BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
K102898 · Panpac Medical Corporation · Dec 2011
FEMCHEC PRESSURE MANAGEMET DEVICE
K110993 · Femasys, Inc. · Oct 2011