# K012695: Vanguard Reprocessed Arthroscopic Wands

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Oct 30, 2001 after 77 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 5 (0 Class I)
- 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) ArthroCare® ArthroWand® Arthroscopic Wands/Electrodes: named in the summary without a submission number
- (no number) Mitek® VAPR® Arthroscopic Wands/Electrodes: named in the summary without a submission number

## Recalls of this device
- Jun 1, 2009 · Not classified · Z-1204-2012: On 06/09/2009, Stryker Sustain ability Solutions, formerly Ascent Healthcare Solutions, recalled lots 674201 & 674290 of their Reprocessed Mitek Arthroscopic Wand due to the lots not being tested in a
- Mar 11, 2008 · Not classified · Z-1681-2008: Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- Mar 11, 2008 · Not classified · Z-1670-2008: Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- Mar 11, 2008 · Not classified · Z-1668-2008: Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- Mar 11, 2008 · Not classified · Z-1667-2008: Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

## Indications for use
When coupled with a compatible electrosurgical unit, an arthroscopic wand electrode is intended for resection, ablation and coagulation of soft tissues, and for hemostasis of blood vessels during arthroscopic procedures (of the knee, shoulder, ankle, elbow and wrist) that utilize a conductive irrigant.

Source page: https://510kreport.com/device/K012695
Methodology: https://510kreport.com/methodology