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FDA 510(k)

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)

K-Number: K210615 · 2022-05-13

ApplicantThompson Surgical Instruments, Inc.
Decision Date2022-05-13
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is a medical device manufactured by Thompson Surgical Instruments, Inc.. It received FDA 510(k) clearance on 2022-05-13 under approval number K210615. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by Thompson Surgical Instruments, Inc.. The 510(k) number is K210615.

When was Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) approved by the FDA?

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) received FDA 510(k) clearance on 2022-05-13, under approval number K210615.

What company makes Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is manufactured by Thompson Surgical Instruments, Inc..

What is the FDA product code for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

The FDA product code for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is GZT.

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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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