K042555 is an FDA 510(k) clearance for the SURGICHIP TAG SURGICAL MARKER. This device is classified as a Marker, Skin (Class I — General Controls, product code FZZ).
Submitted by Surgichip, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on November 9, 2004, 50 days after receiving the submission on September 20, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4660.
| 510(k) Number | K042555 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 20, 2004 |
| Decision Date | November 09, 2004 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZZ — Marker, Skin |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4660 |