Cleared Traditional

K153472 - Quiver Laparoscopic Extendable

K153472 is an FDA 510(k) clearance for Quiver Laparoscopic Extendable, manufactured by Itl Corporation Pty, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code HAM cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K153472 · Itl Corporation Pty, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K153472

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
89d slower than avg
Panel avg: 115d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAM Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HAM Apparatus, Electrosurgical

Devices cleared under the same product code (HAM) and FDA review panel - the closest regulatory comparables to K153472.
LAPAROSTAT(TM)
K913300 · Cook Ob/Gyn · Apr 1992
BARD EMS SYSTEM 6000 E.S.U.
K871435 · C.R. Bard, Inc. · May 1987
ELECTRO-CAUTERY KNIFE CLEANER 6000 1
K852184 · Dlp, Inc. · Jun 1985
OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S
K833648 · Edward Weck, Inc. · Nov 1983
MICRO BI-POLAR FORCEPS #39-200
K771186 · Edward Weck, Inc. · Jul 1977