Cleared Traditional

K153472 - Quiver Laparoscopic Extendable (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153472 · Itl Corporation Pty, Ltd. · General & Plastic Surgery device
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Jun 2016
Decision
204d
Days
Class 2
Risk

K153472 is an FDA 510(k) clearance for the Quiver Laparoscopic Extendable. Classified as Apparatus, Electrosurgical (product code HAM), Class II - Special Controls.

Submitted by Itl Corporation Pty, Ltd. (Chelsea Heights, Vic, AU). The FDA issued a Cleared decision on June 23, 2016 after a review of 204 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Itl Corporation Pty, Ltd. devices

Submission Details

510(k) Number K153472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2015
Decision Date June 23, 2016
Days to Decision 204 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 114d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAM Apparatus, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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.