# K210615: Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)

- Pathway: 510(k) (Traditional)
- Applicant: Thompson Surgical Instruments, Inc.
- Decided: May 13, 2022 after 438 days
- Product code: GZT (Retractor, Self-Retaining, For Neurosurgery)
- Device class: 2
- Regulation: 21 CFR 882.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Greenberg Retractor and Handrest: named in the summary without a submission number

## Indications for use
The Thompson Brain Retractor Table Mounted and Skull Clamp Mounted Systems are indicated for self-retaining retraction of soft tissue during neurological procedures to provide surgical access and exposure. The Thompson Brain Retractor Systems also allow attachment for applicable accessories and function as a hand-rest for the surgeon.

Source page: https://510kreport.com/device/K210615
Methodology: https://510kreport.com/methodology