# K011929: Handpiece Sheath-Model #A910

- Pathway: 510(k) (Traditional)
- Applicant: Aaron Medical, Inc.
- Decided: Sep 18, 2001 after 90 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K871465 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992149: Geiger Electrosurgical Handpiece Sheath, Model 405, Geiger Medical Technologies, Inc. (1999) Summary page 1.
- K983406: Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral Disposable Thermometer Sheaths for, Banta Healthcare Group, Ltd. (1998) Summary page 1.
- K963088: Sheath, Electrosurgical Pencil, Aspen Laboratories, Inc. (1996) Summary page 1.

## Indications for use
The Aaron 910 handpiece Sheath is intended to be used as an accessory to electrosurgical handpieces. The sheath is placed over the handpiece and provides a barrier to minimize contamination. The Handpiece Sheath is non-sterile and is intended for single patient use only.

Source page: https://510kreport.com/device/K011929
Methodology: https://510kreport.com/methodology