Cleared Traditional

UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 (K010296) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010296 · Marina Medical Instruments, Inc. · Obstetrics & Gynecology device
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Apr 2001
Decision
70d
Days
Class 2
Risk

K010296 is an FDA 510(k) clearance for the UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Marina Medical Instruments, Inc. (Hollywood, US). The FDA issued a Cleared decision on April 11, 2001 after a review of 70 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 Marina Medical Instruments, Inc. devices

Submission Details

510(k) Number K010296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2001
Decision Date April 11, 2001
Days to Decision 70 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
90d faster than avg
Panel avg: 160d · This submission: 70d
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 86
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