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

FDA 510(k) K210615 · Thompson Surgical Instruments, Inc.

Substantially Equivalent

510(k) numberK210615

Submission

Device name
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
Applicant
Thompson Surgical Instruments, Inc.
Traverse, MI, US
Received
March 1, 2021
Decision date
May 13, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZT – Retractor, Self-Retaining, For Neurosurgery
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4800
Specialty
Neurology

Other 510(k)s with product code GZT

510(k)DeviceApplicantDecision
K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS…GZT · Traditional Vycor Medical, Inc.01/14/2021SE
K202072MindsEye Expandable PortGZT · Traditional Minnetronix Neuro, Inc.08/26/2020SE
K180610Geister retractor for neuro - and spine surgeryGZT · Traditional Geister Medizin Technik GmbH08/29/2018SE
K172433NICO BrainPathGZT · Special Nico Corporation09/07/2017SE
K161680MEDICON Spinal Spreading SystemsGZT · Traditional Medicon EG03/24/2017SE
K161318Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding…GZT · Traditional Tedan Surgical Innovations, LLC03/20/2017SE
K161004Self-retaining RetractorGZT · Traditional Fetzer Medical GmbH & Co. KG09/09/2016SE
K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookGZT · Traditional Nico Corporation06/12/2015SE
K120691Brain PortGZT · Traditional Nico Corporation06/05/2012SE
K113273Spotlight Access SystemGZT · Traditional Johnson & Johnson01/27/2012SE

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Questions and answers

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

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) (K210615) received a 510(k) decision of Substantially Equivalent on May 13, 2022, 438 days after the submission was received.

What is the product code of K210615?

The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.