Cleared Traditional

K840470 - SURGISCRIBE MARKING PEN

K840470 is an FDA 510(k) clearance for SURGISCRIBE MARKING PEN, manufactured by Surgicot, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FZZ cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K840470 · Surgicot, Inc. · General & Plastic Surgery device
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Mar 1984
Decision
38d
Days
Class 1
Risk

K840470 is an FDA 510(k) clearance for the SURGISCRIBE MARKING PEN. Classified as Marker, Skin (product code FZZ), Class I - General Controls.

Submitted by Surgicot, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 38 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.

View all Surgicot, Inc. devices

FDA 510(k) Submission Details - K840470

510(k) Number K840470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1984
Decision Date March 12, 1984
Days to Decision 38 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 115d · This submission: 38d
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 10
Devices cleared under the same product code (FZZ) and FDA review panel - the closest regulatory comparables to K840470.
DISPOSABLE SKIN MARKING PEN
K843116 · E.M. Adams · Aug 1984
SCANLAN COLORMARK SKIN MARKER
K841085 · Scanlan Intl., Inc. · Jun 1984
SECURLINE SURGICAL SKIN MARKER 1000
K840820 · Precision Dynamics Corp. · Apr 1984
SKIN MARKERS
K821063 · Devon Industries, Inc. · Jun 1982
SURGICAL RULER AND PEN
K790084 · Devon Industries, Inc. · Feb 1979
SKIN MARKING PEN
K781770 · Abco Dealers, Inc. · Nov 1978