Cleared Traditional

K940681 - CLEARVIEW UTERINE MANIPULATOR

K940681 is an FDA 510(k) clearance for CLEARVIEW UTERINE MANIPULATOR, manufactured by Clinical Innovations, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K940681 · Clinical Innovations, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
166d
Days
Class 2
Risk

K940681 is an FDA 510(k) clearance for the CLEARVIEW UTERINE MANIPULATOR. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Clinical Innovations, Inc. (Murray, US). The FDA issued a Cleared decision on July 26, 1994 after a review of 166 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.

View all Clinical Innovations, Inc. devices

FDA 510(k) Submission Details - K940681

510(k) Number K940681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1994
Decision Date July 26, 1994
Days to Decision 166 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 160d · This submission: 166d
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 44
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K940681.
LUMIN
K943448 · Utah Medical Products, Inc. · Apr 1995
UTERINE MANIPULATOR/INJECTOR WITH SPRING
K941458 · Zinnanti Surgical Instruments, Inc. · Jan 1995
UTERINE INJECTOR WITH SPRING
K941457 · Zinnanti Surgical Instruments, Inc. · Jan 1995
AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR
K930867 · United States Surgical, A Division of Tyco Healthc · Jul 1994
OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT
K935434 · United States Surgical, A Division of Tyco Healthc · May 1994
CANNULA: KAHN, JARCO, CORSON AND RATCHET
K930038 · Thomasville Medical Assoc. · Feb 1994