FDA 510(k)

Symmetry Sharp Kerrison Rongeur

K-Number: K161744 · 2016-09-07

Decision Date2016-09-07

Product CodeHAE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Symmetry Sharp Kerrison Rongeur is a medical device manufactured by Symmetry Surgical, Inc.. It received FDA 510(k) clearance on 2016-09-07 under approval number K161744. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Symmetry Sharp Kerrison Rongeur?

Symmetry Sharp Kerrison Rongeur is a medical device that received FDA 510(k) clearance on 2016-09-07. It is manufactured by Symmetry Surgical, Inc.. The 510(k) number is K161744.

When was Symmetry Sharp Kerrison Rongeur approved by the FDA?

Symmetry Sharp Kerrison Rongeur received FDA 510(k) clearance on 2016-09-07, under approval number K161744.

What company makes Symmetry Sharp Kerrison Rongeur?

Symmetry Sharp Kerrison Rongeur is manufactured by Symmetry Surgical, Inc..

What is the FDA product code for Symmetry Sharp Kerrison Rongeur?

The FDA product code for Symmetry Sharp Kerrison Rongeur is HAE.

Other Devices by Symmetry Surgical, Inc.

K152111Symmetry Surgical Quad-Lock Container System K173272Ergonomic Handle

Related Devices (Code: HAE)

K153243Fehling-PunchesFehling Instruments GmbH & Co. KG K152734Kerrison RongeursVitalitec Medizintechnik GmbH K150468Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursK2 Medical GmbH & Co. KG K180949SteribiteRjr Surgical, Inc. K200383Wiggins Medical Surgical InstrumentsWiggins Medical K200387Ace Medical Surgical InstrumentsAce Medical

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.