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FDA 510(k)

GammaPod - Model A

K-Number: K172706 · 2017-12-22

ApplicantXcision Medical Systems, LLC
Decision Date2017-12-22
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GammaPod - Model A is a medical device manufactured by Xcision Medical Systems, LLC. It received FDA 510(k) clearance on 2017-12-22 under approval number K172706. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GammaPod - Model A?

GammaPod - Model A is a medical device that received FDA 510(k) clearance on 2017-12-22. It is manufactured by Xcision Medical Systems, LLC. The 510(k) number is K172706.

When was GammaPod - Model A approved by the FDA?

GammaPod - Model A received FDA 510(k) clearance on 2017-12-22, under approval number K172706.

What company makes GammaPod - Model A?

GammaPod - Model A is manufactured by Xcision Medical Systems, LLC.

What is the FDA product code for GammaPod - Model A?

The FDA product code for GammaPod - Model A is IWB.

Other Devices by Xcision Medical Systems, LLC

K180571GammaPod

Related Devices (Code: IWB)

K160440Leksell Gamma Knife IconElekta Instrument AB K180571GammaPodXcision Medical Systems, LLC K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB K173791Leksell GammaPlanElekta Instrument AB K190844Akesis GalaxyAkesis, Inc. K200050Akesis Galaxy RTxAkesis, 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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