Cleared Traditional

K904079 - BARD UTERINE MANIPULATOR

K904079 is the FDA 510(k) clearance for BARD UTERINE MANIPULATOR by C.R. Bard, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code LKF) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K904079 · C.R. Bard, Inc. · Obstetrics & Gynecology device
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Feb 1991
Decision
155d
Days
Class 2
Risk

K904079 is an FDA 510(k) clearance for the BARD UTERINE MANIPULATOR. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on February 7, 1991 after a review of 155 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K904079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1990
Decision Date February 07, 1991
Days to Decision 155 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 160d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 42
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K904079.
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
MAJOLI UTERINE MANIPULATOR/INJECTOR
K911887 · Cook Ob/Gyn · Jul 1991
TWIN BALLOON INJECTOR
K902975 · Zinnanti Surgical Instruments, Inc. · Sep 1990