Cleared Traditional

K911887 - MAJOLI UTERINE MANIPULATOR/INJECTOR

K911887 is the FDA 510(k) clearance for MAJOLI UTERINE MANIPULATOR/INJECTOR by Cook Ob/Gyn. It is a Class 2 Obstetrics & Gynecology device (product code LKF) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K911887 · Cook Ob/Gyn · Obstetrics & Gynecology device
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Jul 1991
Decision
88d
Days
Class 2
Risk

K911887 is an FDA 510(k) clearance for the MAJOLI UTERINE MANIPULATOR/INJECTOR. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on July 26, 1991 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Ob/Gyn devices

Submission Details

510(k) Number K911887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1991
Decision Date July 26, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 160d · This submission: 88d
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 K911887.
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
BARD UTERINE MANIPULATOR
K904079 · C.R. Bard, Inc. · Feb 1991
TWIN BALLOON INJECTOR
K902975 · Zinnanti Surgical Instruments, Inc. · Sep 1990