Not Cleared Direct

DEN170075 - ContainOR (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170075 · Advanced Surgical Concepts, Ltd. · General & Plastic Surgery device
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Dec 2017
Decision
81d
Days
Class 2
Risk

DEN170075 is an FDA 510(k) submission (not cleared) for the ContainOR. Classified as General Laparoscopic Power Morcellation Containment System (product code PZQ), Class II - Special Controls.

Submitted by Advanced Surgical Concepts, Ltd. (Bray, IE). The FDA issued a Not Cleared (DENG) decision on December 19, 2017 after a review of 81 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4825 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the General & Plastic Surgery review framework.

View all Advanced Surgical Concepts, Ltd. devices

Submission Details

510(k) Number DEN170075 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 29, 2017
Decision Date December 19, 2017
Days to Decision 81 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 114d · This submission: 81d
Pathway characteristics

Device Classification

Product Code PZQ General Laparoscopic Power Morcellation Containment System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4825
Definition Intended For Use As A Bag Containment System By Qualified Surgeons For Tissue Extraction And/or Power Morcellation During General Laparoscopic Procedures.
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 General & Plastic Surgery devices follow this clearance model.