# K093054: Scalp Dura Retractor, Model KS00474

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Nov 15, 2010 after 411 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: 2 generations back to K830332 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060097: Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00, KLS-Martin L.P. (2006)
- K960807: Tew Cranial/Spinal Retractor Model A1090, Ohio Medical Instrument Co., Inc. (1996) Summary page 1.
- K830332: Budde-Halo Retractor, Ohio Medical Instrument Co., Inc. (1983) Summary page 1.

## Indications for use
The Karl Storz Scalp Dura Retractor is intended for use to elevate dura and scalp layers away from cranial bone during endoscopic-assisted strip craniectomies.

Source page: https://510kreport.com/device/K093054
Methodology: https://510kreport.com/methodology