Cleared Traditional

K042555 - SURGICHIP TAG SURGICAL MARKER

K042555 is an FDA 510(k) clearance for SURGICHIP TAG SURGICAL MARKER, manufactured by Surgichip, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FZZ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K042555 · Surgichip, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
50d
Days
Class 1
Risk

K042555 is an FDA 510(k) clearance for the SURGICHIP TAG SURGICAL MARKER. Classified as Marker, Skin (product code FZZ), Class I - General Controls.

Submitted by Surgichip, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on November 9, 2004 after a review of 50 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4660 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042555

510(k) Number K042555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

FZZ Device Classification - Class 1, General Controls

Product Code FZZ Marker, Skin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FZZ Marker, Skin

All 21
Devices cleared under the same product code (FZZ) and FDA review panel - the closest regulatory comparables to K042555.
DISPOSABLE SKIN MARKER
K915066 · American Medical Mfg., Inc. · May 1992
BLOOM TRANSPARENT STENCIL
K914759 · Freckles Publications, Inc. · Apr 1992
ROCKET SURGICAL SKIN MARKING PEN
K912730 · West Texas Lighthouse For the Blind · Nov 1991
SKIN MARKER
K905143 · Aesculap, Inc. · Feb 1991
QUALTEX SKIN MARKER
K904559 · Qualtex, Inc. · Dec 1990
SURGICAL SKIN MARKER
K896792 · Westmark, Sterile Packing Systems, Inc. (Sps) · Dec 1989
K042555 · SURGICHIP TAG SURGICAL MARKER
Download PDF FDA Summary Surgichip, Inc.