Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Thompson Surgical Instruments, Inc.. It received FDA 510(k) clearance on 2022-05-13 under 510(k) 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. The listed applicant is Thompson Surgical Instruments, Inc.. The 510(k) number is K210615.

When did Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) receive FDA 510(k) clearance?

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

Who is the listed applicant for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

The FDA 510(k) record lists Thompson Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: GZT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)Vycor Medical, Inc.K202072MindsEye Expandable PortMinnetronix Neuro, Inc.K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbHK172433NICO BrainPathNico CorporationK161680MEDICON Spinal Spreading SystemsMedicon EGK161318Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding SystemsTedan Surgical Innovations, LLC

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.

↑