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FDA 510(k)

Penumbra Smart Coil

K-Number: K160832 · 2016-04-20

ApplicantPenumbra, Inc.
Decision Date2016-04-20
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Penumbra Smart Coil is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2016-04-20 under approval number K160832. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Penumbra Smart Coil?

Penumbra Smart Coil is a medical device that received FDA 510(k) clearance on 2016-04-20. It is manufactured by Penumbra, Inc.. The 510(k) number is K160832.

When was Penumbra Smart Coil approved by the FDA?

Penumbra Smart Coil received FDA 510(k) clearance on 2016-04-20, under approval number K160832.

What company makes Penumbra Smart Coil?

Penumbra Smart Coil is manufactured by Penumbra, Inc..

What is the FDA product code for Penumbra Smart Coil?

The FDA product code for Penumbra Smart Coil is HCG.

Other Devices by Penumbra, Inc.

K161506Penumbra Aspiration System K161640Penumbra System ACE 68 Reperfusion Catheter K161523INDIGO Aspiration System K161064Penumbra System ACE 68 Reperfusion Catheter K160449Penumbra System, Penumbra Pump MAX K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

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Related Devices (Code: HCG)

K161367HydroCoil Embolic System (HES)MicroVention, Inc. K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc. K161429Target Detachable CoilsStryker Neurovascular K153658Target Detachable CoilsStryker Neurovascular K160096InZone Detachment SystemStryker Neurovascular K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.

Official Source

View on FDA Database →

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

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