Cleared Special

OCTOTMPORT (K112196) - FDA 510(k) Clearance

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

K112196 · Dalim Surgnet Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
44d
Days
Class 2
Risk

K112196 is an FDA 510(k) clearance for the OCTOTMPORT. Classified as Laparoscopic Single Port Access Device (product code OTJ), Class II - Special Controls.

Submitted by Dalim Surgnet Corporation (Brea, US). The FDA issued a Cleared decision on September 14, 2011 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dalim Surgnet Corporation devices

Submission Details

510(k) Number K112196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2011
Decision Date September 14, 2011
Days to Decision 44 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OTJ Laparoscopic Single Port Access Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition A Multiple Instrument And/or Camera Port During Minimally Invasive Abdominal Laparoscopic Surgery.
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.