Cleared Traditional

K061679 - WALLACE ARTIFICIAL INSEMINATION CATHETER

K061679 is an FDA 510(k) clearance for WALLACE ARTIFICIAL INSEMINATION CATHETER, manufactured by Irvine Scientific Sales Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K061679 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
120d
Days
Class 2
Risk

K061679 is an FDA 510(k) clearance for the WALLACE ARTIFICIAL INSEMINATION CATHETER. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 13, 2006 after a review of 120 days - within the typical 510(k) review window.

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.

View all Irvine Scientific Sales Co., Inc. devices

FDA 510(k) Submission Details - K061679

510(k) Number K061679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2006
Decision Date October 13, 2006
Days to Decision 120 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
40d faster than avg
Panel avg: 160d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 - LKF Cannula, Manipulator/injector, Uterine

All 46
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K061679.
PROBE HOLDER SYSTEM
K071405 · Intuitive Surgical, Inc. · Oct 2007
VCARE RETRACTOR/ELEVATOR
K071907 · Conmed Corporation · Oct 2007
SALINE/ CONTRAST MEDIA INFUSION CATHETER
K063611 · Utah Medical Products, Inc. · May 2007
INTRAUTERINE VENOGRAM NEEDLE SET
K041062 · Cook Urological, Inc. · Oct 2004
SIB CATHETER, MODEL 61-7005
K021272 · Ackrad Laboratories · May 2002
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
K020954 · Ackrad Laboratories · Apr 2002