# K042555: Surgichip Tag Surgical Marker

- Pathway: 510(k) (Traditional)
- Applicant: Surgichip, Inc.
- Decided: Nov 9, 2004 after 50 days
- Product code: FZZ (Marker, Skin)
- Device class: 1
- Regulation: 21 CFR 878.4660
- Recalls of this device: none
- 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) Skin Marker: named in the summary without a submission number
- (no number) Adhesive Surgical Site Marker: named in the summary without a submission number
- (no number) RFID Hospital Identification Wristband: named in the summary without a submission number

## Indications for use
The SURGICHIP Tag surgical marker is indicated to mark an anatomical site for surgery.

Source page: https://510kreport.com/device/K042555
Methodology: https://510kreport.com/methodology