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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Resources, Inc.
Emily Rossiter

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.

Regulatory Peers - HAM Apparatus, Electrosurgical

All 15
Devices cleared under the same product code (HAM) and FDA review panel - the closest regulatory comparables to K153472.
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K993306 · Paladin Medical, Inc. · Nov 1999
BERGEN 710 ESU
K945861 · Bergen Mfg. · Mar 1995
LAPAROSTAT(TM)
K913300 · Cook Ob/Gyn · Apr 1992
GSU HANDPIECE ADAPTER
K920100 · Beacon Laboratories, Inc. · Feb 1992
EMC MODEL NO. STATOME 900
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K153472 · Quiver Laparoscopic Extendable
Download PDF FDA Summary Itl Corporation Pty, …