# K060097: Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Feb 27, 2006 after 45 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
Longest line of descent: 1 generation back to K830332 (1983). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830332: Budde-Halo Retractor, Ohio Medical Instrument Co., Inc. (1983) Summary page 1.
- K960807: Tew Cranial/Spinal Retractor Model A1090, Ohio Medical Instrument Co., Inc. (1996) Summary page 1.

## Most influential descendants
- K180610: Geister retractor for neuro - and spine surgery (2018), 1 descendant of its own
- K252995: Durashield Device Kit (2026), 0 descendants of its own
- K093054: Scalp Dura Retractor, Model KS00474 (2010), 0 descendants of its own

## Indications for use
The Grossman Self-Retaining Low Profile Brain Retractor is designed to retract soft tissue during neurosurgical procedures.

Source page: https://510kreport.com/device/K060097
Methodology: https://510kreport.com/methodology