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FDA 510(k)

Quiver Laparoscopic Extendable

K-Number: K153472 · 2016-06-23

Decision Date2016-06-23
Product CodeHAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Quiver Laparoscopic Extendable is the device name listed in this FDA 510(k) record. The listed applicant is Itl Corporation Pty, Ltd.. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K153472. The device is classified under product code HAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quiver Laparoscopic Extendable?

Quiver Laparoscopic Extendable is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Itl Corporation Pty, Ltd.. The 510(k) number is K153472.

When did Quiver Laparoscopic Extendable receive FDA 510(k) clearance?

Quiver Laparoscopic Extendable received FDA 510(k) clearance on 2016-06-23, under 510(k) number K153472.

Who is the listed applicant for Quiver Laparoscopic Extendable?

The FDA 510(k) record lists Itl Corporation Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quiver Laparoscopic Extendable?

The FDA product code for Quiver Laparoscopic Extendable is HAM.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.