Cleared Traditional

K212659 - More-Cell-System (FDA 510(k) Clearance)

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

K212659 · Agency For Medical Innovations GmbH · Obstetrics & Gynecology device
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Nov 2021
Decision
79d
Days
Class 2
Risk

K212659 is an FDA 510(k) clearance for the More-Cell-System. Classified as Containment System, Laparoscopic Power Morcellation, With Instrument Port (product code PMU), Class II - Special Controls.

Submitted by Agency For Medical Innovations GmbH (Feldkirch, AT). The FDA issued a Cleared decision on November 10, 2021 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4050 - 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 Agency For Medical Innovations GmbH devices

Submission Details

510(k) Number K212659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2021
Decision Date November 10, 2021
Days to Decision 79 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
81d faster than avg
Panel avg: 160d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4050
Definition Use As A Multiple Instrument Port And Tissue Containment System During Minimally Invasive Gynecologic Laparoscopic Surgery To Enable The Isolation And Containment Of Tissue Considered Benign, Resected During Single-port Or Multi-site Laparoscopic Surgery During Power Morcellation And Removal. The Device Is Compatible With Bipolar Or Electromechanical Laparoscopic Power Morcellators That Are Between 15 Mm And 18 Mm In Shaft Outer Diameter And 135 Mm And 180 Mm In Shaft Working Length And Which Have An External Component That Allows For The Proper Orientation Of The Laparoscope To Perform A Contained Morcellation.
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 Consultant

Acknowledge Regulatory Strategies, LLC
Allison Komiyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.