# K022712: Hand Drill, Model 11-9901-7

- Pathway: 510(k) (Traditional)
- Applicant: Medical Design, LLC
- Decided: Nov 12, 2002 after 90 days
- Product code: HBG (Drills, Burrs, Trephines & Accessories (Manual))
- Device class: 2
- Regulation: 21 CFR 882.4300
- 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 K862160 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862160: Camino Hand Drill - Model 030, Camino Laboratories, Inc. (1986) Summary page 1.

## Most influential descendants
- K032125: Cstat, Models 09-0014-01 and 09-0014-02 (2004), 0 descendants of its own

## Indications for use
The Medical Designs Hand Drill is intended for use in Neurosurgical procedures and for use with Medical Designs’ Subdural Evacuating Port System Kit (S.E.P.S),Catalog # 11 - 9901. The Hand Drill is not intended for any use other than that indicated.

Source page: https://510kreport.com/device/K022712
Methodology: https://510kreport.com/methodology